Sterile site apparatus, system, and method of using the same

ABSTRACT

Apparatus, system, and methods are provided for reducing infectious agents at a sterile site by preventing infectious agents from coming into contact with the sterile site. A barrier is produced for infectious agents that may come in proximity or otherwise communicate with the site. The apparatus is configured to create a void-free barrier in which infectious agents are reduced with minimal exposure of potentially harmful effects of the barrier to the sterile site, objects, or users of the apparatus.

CROSS REFERENCE TO RELATED APPLICATION

This application is a Continuation patent application of U.S.application Ser. No. 16/379,975, filed Apr. 10, 2019, which is aContinuation patent application of U.S. application Ser. No. 15/443,860,filed Feb. 27, 2017 (now U.S. Pat. No. 10,299,882, issued May 28, 2019)which is a Divisional patent application of U.S. application Ser. No.14/384,557, filed Sep. 11, 2014 (now U.S. Pat. No. 9,615,884, issuedApr. 11, 2017), which is the U.S. National Phase application of PCTInternational Application No. PCT/US2013/030815, filed Mar. 13, 2013,and claims priority to U.S. Provisional Application Ser. No. 61/610,840,filed Mar. 14, 2012, each of which applications is incorporated hereinby reference in their entireties and for all purposes.

FIELD OF THE INVENTION

This invention relates generally to an apparatus, system, and method forthe reduction of infectious agents at a sterile site, and morespecifically to apparatuses, systems, and methods which create a barrierin order to inhibit sterile site contamination.

BACKGROUND OF THE INVENTION

Healthcare associated infections (HAIs) result in a significant cause ofmorbidity and mortality in the United States. In 2002, the estimatednumber of HAIs in U.S. hospitals, adjusted to include federalfacilities, was approximately 1.7 million. The overall annual directmedical costs of HAI to U.S. hospitals ranges from $28.4 to $33.8billion.

The most significant types of HAIs are central line-associatedbloodstream infection (CLABSI), Clistridium difficile Infection (CDI, C.diff), Surgical Site Infection (SSI), Catheter-associated urinary tractinfection (CAUTI), and Ventilator-associated pneumonia (VAP) whichcombined account for roughly two thirds of all HAIs in the US. TheCenters for Disease Control and Prevention (CDC) provide substantialinformation and resources in characterizing these and other infections.This information may be found athttp://www.cdc.gov/HAI/infectionTypes.html and is incorporated into thebackground by reference.

In general, HAIs arise from patient- and procedure-specific riskfactors. Host-specific factors include patient co-morbidities such ashemodialysis, diabetes, or age. Such inherent risk factors are noteasily modifiable, with little opportunity for intervention to reduceinfection risks. See, Uslan, Daniel Z. Overview of Infections of CardiacRhythm Management Devices. EP Lab Digest, Supplement to May 2009.Procedure-associated risks correlate with a high rate of surgical siteinfection (SSI) and catheter related infections due to factors such asinpatient or outpatient treatment, length of procedure time, and venueof surgical theatre (operating room or catheterization lab). Inaddition, there are also infection risks related to the use ofbiotechnology, in which the patient is susceptible to exposure fromdiagnostic equipment (endoscope/laparoscope) and implants (hipprosthesis, cardiac rhythm management devices/CRMDs), including bothautograft and allograft transplants.

All surgical procedures involve a small but serious risk of infection.However, infections involving CRMDs are specifically difficult toresolve due to the presence of prosthetic material within the body. CRMDinfections result in a substantial cost to the healthcare system becausethe implanted hardware must be extracted and replaced. See, Reynolds,Matthew R. The Health Economic Consequences of Cardiac Rhythm DeviceInfections. EP Lab Digest, Supplement to May 2009. Reducing orpreventing HAI's are a function of reducing infectious agents colonizingin an area that can result in an infection to the body.

Adherence to the principles of sterile technique is crucially importantin achieving asepsis in the operating room complex. Prior toreprocessing to achieve disinfection or sterility, any instrument orequipment must be properly cleaned using the following: a detergent orenzymatic cleaner, an ultrasonic cleaner, or an automated washer.Disinfection involves the physical or chemical cleaning which renders anobject or surface free from dangerous microbial life, allowing it to besafely handled. Sterilization is the process of eradicating all evidenceof live micro-organisms, including spores. The integrity of the surgicalsite is preserved by keeping the surgical team gowned and gloved, withthe use of sterile items confined to the level of table height withinthe sterile field, which is created as close as possible to the time ofuse. During a surgical intervention, sterile persons must touch onlysterile items; they must also remain within the sterile area and avoidreaching over an unsterile area.

Despite compliance to rigorous infection control protocols,micro-organisms with nosocomial infection potential are still present inthe hospital environment: Clostridium Difficile, Methicillin-ResistantStaphylococcus Aureus, Staphylococci, Enterococci, Pseudomonas,Streptococci, and Vancomycin-Resistant Enterococcus. See, Malan, Kim.Registered Nurses' Knowledge of Infection Control and Sterile TechniquePrinciples in the Operating Room Complex of Private Hospitals. NelsonMandela Metropolitan University. 2009. This may be explained by a 2009study which evaluated sanitation procedures in operating rooms; itestablished that after cleaning, the post sanitation bacterial loadresumed an increase in levels of total microbial count, depending on thematerial of the surface and its horizontal or vertical disposition. See,Fabretti, Alessia, PhD, et al. Experimental Evaluation of the Efficacyof Sanitation Procedures in Operating Rooms. Association forProfessionals in Infection Control and Epidemiology, Inc. 2009.

Due to the resurgence of micro-organisms which contribute to SSI,different apparatuses and methods have been developed to enhancesanitation levels in the operating complex. Instruments which cannot besterilized must be disinfected using thermal pasteurization or chemicalinactivation. Pasteurization is not compatible with all instruments, asit requires a high tolerance for heat and moisture processing. Thepractice of chemical disinfection also encounters some limitations; onlyinstrument-grade disinfectants are suitable for use with medicalinstruments and equipment. Glutaraldehyde is most effective forinactivating all microbial pathogens except where there is a largepresence of bacterial spores, but it must be used under strictlycontrolled conditions in a safe working environment. See, World HealthOrganization. Practical Guidelines for Infection Control in Health CareFacilities. SEARO Regional Publication No. 41. 2004. The CDC haspublished a comprehensive reference entitled Guideline for Disinfectionand Sterilization in Healthcare Facilities, 2008 which is included inits entirety by reference herein.

Medical devices which penetrate sterile body sites must be sterilizedthrough either physical or chemical methods to eliminate allmicro-organisms. The most common physical method for sterilizationinvolves using heat to oxidize the proteins in microbes. However, thedry heat which is produced by incineration devices such as the Bunsenburner or the hot-air oven take several hours to achieve sterilization.Moist heat can also destroy micro-organisms using boiling water,pasteurization, autoclaving, or tyndallization. While these techniquesare able to kill microbes by denaturing their proteins, they alsorequire many hours to eliminate bacterial spores.

A few physical methods which control the growth and presence ofmicro-organisms do not involve heat. Filtration is a process by whichliquids or gases are passed through a series of pores small enough totrap the micro-organisms. The filtration medium may be comprised ofnitrocellulose membranes or diatomaceous earth. Drying is a processwhich eradicates microbes by removing water from their cells. Anothertechnique for drying involves lyophilization, which quick freezesliquids and then subjects them to evacuation. While cold temperaturescan slow down bacterial growth, freezing temperatures kill manymicro-organisms by forming ice crystals. These various methods allrequire an investment of time to perform some repetitive cycling of theprocess while the microbes are eradicated. See, Alcamo, I. Edward, PhD.Cliffs Quick Review Microbiology. Wiley Publishing. 1996.

The use of radiation also provides a physical form of sterilization.Radiation can be emitted in different forms such as microwave,ultraviolet (UV) light, pulsed UV, broad spectrum pulsed light (BSPL)electron beam, and pulsed electrical field (PEF). The direct effect ofmicrowave on microbes is minimal; water molecules will vibrate at themicrowave frequency, creating heat. This high temperature is the agentwhich atomizes the micro-organism and kills it, rather than themicrowave itself. Though not a form of radiation, ultrasonic atomizationis similar to microwave atomization in that a shock wave is used toinduce the expansion of water droplets, which would then atomize anybioaerosols in the airstream.

A common form of radiation involves the use of UV light emitted from amercury lamp, which is directed as a single photon that can penetrate amicro-organism and disassociate its DNA. Shortwave ultraviolet light, orgermicidal UV-C, can kill bacteria at a wavelength between 200-280 nm.It is commonly employed at 254 nm for air, water, and surfacedisinfection, but the lethal wavelength to inactivate micro-organismsvaries with the kind of bacteria, spores, viruses, mold, yeast, andalgae, as well as their exposure time to that specific intensity. See,Andersen, B. M., MD, PhD, et al. Comparison of UV C Light and Chemicalsfor Disinfection of Surfaces in Hospital Isolation Units. InfectionControl and Hospital Epidemiology. July 2006. Higher wavelengthspenetrate the contaminated surface more thoroughly, but more intenseradiation produces more heat, which may not be suitable for allsterilization applications.

As a source of UV radiation, an alternative to continuous mercury lampsis the pulsed xenon arc or xenon flashlamp. Compared to continuous wavesources such as mercury lamps, the pulsed xenon flashlamp is moreefficient in its conversion of electrical energy to light energy, whileits output of light intensity in the critical 200-300 nm wavelengthregion is substantially greater. See, Lamont, Y. et al. Pulsed UV-lightinactivation of poliovirus and adenovirus. Letters in AppliedMicrobiology 45, 2007, pages 564-567. This technology killsmicro-organisms by emitting very brief pulses of an intense broadbandemission spectrum which is rich in UV-C germicidal light. A continuous10 W mercury lamp would have to be operated for 10 seconds to achievethe same sterility level as a 1 MW pulsed xenon lamp operated for just100 μs. See, Farrell, H. P. et al. Investigation of criticalinter-related factors affecting the efficacy of pulsed light forinactivating clinically relevant bacterial pathogens. Journal of AppliedMicrobiology 106, 2010, pages 1494-1508. In 1996, the Food and DrugAdministration approved the use of pulsed light technology for microbialinactivation for alternative food processing technology under thecondition that xenon flashlamps are used as the pulse light source andthe cumulative treatment does not exceed 12 J/cm². See, Woodling, Sarahand Carmen Moraru. Effect of Spectral Range in Surface Inactivation ofListeria Innocua Using Broad-Spectrum Pulsed Light. Journal of FoodProtection. Vol 70, No. 4, 2007, pages 909-916. Pulsed light radiationinvolves the use of intense and short duration of broad-spectrum “whitelight,” which includes wavelengths in the ultraviolet, through thevisible, to the near infrared region. In one commercial applicationacknowledged by the FDA, the material to be disinfected is exposed to atleast 1 pulse of light having a range of energy density between 0.01 to50 J/cm² at the surface. Each pulse of light is typically comprised of 1to 20 flashes per second. The wavelength is distributed so that at least70% of the electromagnetic energy is within the broad spectrum range of170 to 2600 nm. Broad spectrum pulsed light (BSPL) can be delivered atan intensity which is 20,000 times greater than sunlight at the earth'ssurface, though the intense flashes of light may be less than 1millisecond in duration. Because several pulses can be generated persecond, BSPL can perform sterilization at a faster rate than otherconventional processes for physical sterilization, and its efficacy hasbeen tested against a broad range of micro-organisms, includingbacteria, spores, fungi, viruses, and protozoa. See, Food and DrugAdministration. Kinetics of Microbial Inactivation for Alternative FoodProcessing Technologies—Pulsed Light Technology.http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm103058.htm.

Another alternative source of UV radiation is the light emitting diode(LED), though until recently, LED's lacked the efficiency and longevityto be effective for sterilization. Recent developments from companieslike UV Craftory Co (Aichi, Japan), crystal IS (Green Island, N.Y.), andSensor Electronic Technology, Inc. (Columbia, S.C.) have enabled UV LEDtechnology to be more practical for commercial applications. Thebenefits are low heat generation, low power consumption, instant on andoff control, and the ability to produce narrow wavelength distributionsin the UV-A, UV-B, and UV-C spectrums. A narrow wavelength distributionin the UVC spectrum is especially useful when there is concern for thesafety of the radiation in contact with the user or sterile site.

Yet another alternative source of UV radiation is a UV laser, wherecoherent UV radiation is produced by a laser diode, an excimer laser, orany other viable means of producing UV radiation that has limiteddiffraction and whose phase is relatively correlated along the beam. Theadvantage to using UV-C to disinfect surfaces is that it requires arelatively short exposure time without necessary manual labor. UV-C alsohas little impact on the environment; it leaves no residues and does notproduce drug-resistant micro-organisms. However, UV-C may cause somedegradation over time on various materials including plastics andrubbers. It also has the disadvantage of possessing a low penetratingeffect (1-2 mm), so measures must be taken to reduce any shadowing inthe surgical field.

Ultraviolet Dosage Required For 99.9% Destruction of Various Organisms(μW-s/cm² at 254 nanometer) Bacteria Bacillus anthracts 8,700 B.enteritidis 7,600 B. Megatherium sp. (vegatative) 2,500 B. Megatheriumsp. (spores) 52,000 B. paratyphosus 6,100 B. subtilis (vegatative)11,000 B. subtilis (spores) 58,000 Clostridium tetani 22,000Corynebacterium diphtheria 6,500 Eberthella typhosa 4,100 Escherichiacoli 7,000 Leptospira interrogans 6,000 Micrococcus candidus 12,300Micrococcus sphaeroides 15,400 Mycobacterium tuberculosis 10,000Neisseria catarrhalis 8,500 Phytomonas tumefaciens 8,500 Proteusvulgaris 6,600 Pseudomonas aeruginosa 10,500 Pseudomonas fluorescens6,600 Salmonella enteritidis 7,600 Salmonella paratyphi 6,100 Salmonellatyphimurium 15,200 Salmonella typhosa (Typhoid) 6,000 Sarcina lutea26,400 Serratia marcescens 6,200 Shigella dysenteriae (Dysentery) 4,200Shigella paradysenteriae 3,400 Spirillum rubrian 6,160 Staphylococcusalbus 5,720 Staphylococcus aureus 6,600 Streptococcus hemolyticus 5,500Streptococcus lactis 8,800 Streptococcus viridans 3,800 Vibrio cholerae6,500 Mold Spores Aspergillus flavus 99,000 Aspergillus glaucus 88,000Aspergillus niger 330,000 Mucor racemosus A 35,200 Mucor racemosus B35,200 Oospora lactis 11,000 Penicillium digitatum 88,000 Penicilliumexpansum 22,000 Penicillium roqueforti 26,400 Rhizopus nigricans 220,000Algae / Protozoa Chlorella vulgaris (algae) 22,000 Nematode eggs 92,000Paramecium 200,000 Virus Bacteriophage (E. coli) 6,000 Hepatitis virus8,000 Influenza virus 6,600 Polio virus 6,000 Rotavirus 24,000 Tobaccomosaic 440,000 Yeast Baker's yeast 8,800 Brewer's yeast 6,600 Commonyeast cake 13,200 Saccharomyces cerevisiae 13,200 Saccharomycesellipsoideus 13,200 Saccharomyces sp. 17,600

Another application of radiation as a physical form of sterilizationinvolves the use of pulsed electrical field (PEF), which is producedwhen high-voltage electrodes are charged and discharged in fractions ofa second. PEF has been used to induce microbial inactivation by creatinga disruption of cell membranes in micro-organisms. This process emits anintense electrical field which exceeds the cell's critical transmembranepotential. The efficacy of PEF for use in sterilization is affected bymany factors such as the intensity of the electric field, the number ofpulses, the pulse duration, the processing temperature, the type oforganism, the electrical conductivity, and the pH of the medium orcontact surface. See, Wȩsierska, Ewelina and Tadeusz Trziszka.Evaluation of the use of pulsed electrical field as a factor withantimicrobial activity. Journal of Food Engineering 78. pp. 1320-1325.2007. The shape of the wave pulse is also an important variant; electricfield pulses may be applied in several forms: exponential decays, squarewaves, oscillatory, bipolar, or instant reverse charges. For microbialinactivity, oscillatory pulses are the least efficient, while squarewave pulses are more lethal and energy efficient than exponentialdecaying pulses. Bipolar pulses are more destructive to micro-organismsthan monopolar pulses because a PEF causes charged molecules to movewithin their cell membranes. A reverse orientation in the polarity ofthe field causes the molecules to change directions, so that thealternating bipolar pulses create stresses in the cell membrane whichcontribute to its electrical disintegration. The instant reverse chargeis a pulse which is partially positive at the moment of initiation butthen becomes partially negative directly afterward. An increase in theelectrical conductivity of the treated medium will decrease both thepositive and the negative intervals of the pulse, producing an increasein the overall peak voltage ratio. Compared to other pulse waveforms,the instant reverse charge can be 5× more efficient for inactivatingmicro-organisms.

Cold atmospheric plasma (CAP) has also been used successfully forsterilization without damaging healthy tissue. Numerous components ofthe plasma including reactive oxygen or nitrogen species, chargedparticles, electric fields, and UV radiation are involved in theseeffects. Both physical mechanisms caused by reactive species, freeradicals, and UV photons, as well as biological mechanisms are thoughtto be responsible for the inactivation of bacteria. See, Heinlin, Julia,et al. Plasma medicine: possible applications in dermatology. JDDG; 20108, page 1. CAP also has the benefit of stimulating wound healing, andhas been used successfully in reducing the time for surgical wounds toheal while minimizing scarring.

Chemical methods for controlling microbial growth involve the use ofphenol, halogens such as iodine and chlorine, alcohols, heavy metals,aldehydes, ethylene oxide, and oxidizing agents such as nitric oxide,nitrogen dioxide, hydrogen peroxide, benzoyl peroxide, and ozone. Due totheir ease of use, chemicals have been vastly employed forsterilization. However, they may result in adverse effects by alteringthe nature of treated surfaces or by propagating odorous reactions orbiohazardous substances. See, Mori, Mirei, et al. Development of a newwater sterilization device with a 365 nm UV-LED. Medical and BiologicalEngineering and Computing. 2007.

Antimicrobial drugs are chemicals which kill micro-organisms or inhibittheir growth. By damaging the plasma membrane or interfering with DNAreplication and transcription, by disrupting the synthesis of nucleicacids, proteins, or metabolic products, these drugs destroy pathogensthrough cell lysis. The disadvantage to using antimicrobial agents isthat these drugs attack not only the infectious organisms, but theindigenous flora as well, compromising the host's normal defensivecapacity. Broad spectrum antimicrobials target pathogenic organisms aswell as micro-organisms in the host. However, in some instances, acompeting micro-organism may develop resistance against theantimicrobial drug, resulting in its overgrowth. See, Research andEducation Association. Microbiology Super Review. REA. 2006.

Recent developments in technology to prevent SSI have resulted in acombination of physical and chemical sterilization techniques. This mayhave been motivated by the emergence of more sophisticated medicalinstruments and devices which are sensitive to heat and moisture, andthus inspired the creation of low temperature alternatives to steam anddry heat sterilization processes. Ethylene oxide (EtO), which wasintroduced in the early 1950s, has been the standard among hospitals forlow temperature sterilization. Though it is a very effectivemicrobiocidal agent, EtO is an odorless, colorless gas which can becometoxic if handled improperly. It also requires a cycle time of 8-12hours. No other suitable alternative was available until paracetic acidwas introduced in 1988. However, instruments sterilized with paraceticacid must be used immediately, creating a dependence on “just-in-timeprocessing.” See, Ackert-Burr, Cheri, RN, MSN. Low TemperatureSterilization: Are You In The Know? Perioperative Nursing Clinics 5.pages 281-290. 2010. The use of ozone gas and hydrogen peroxide gasplasma for low temperature sterilization provides a quick cycling timewithout the dangers of toxic residuals. A recent study also demonstratedthat in-flight bacteria inactivation may be achieved using ozone andnonthermal plasma, which is derived from a dielectric barrier gratingdischarge. See, Vaze, Nachiket D. et al. Inactivation of Bacteria inFlight by Direct Exposure to Nonthermal Plasma. IEEE Transactions onPlasma Science, Vol. 38, No. 11. November 2010.

Ozone is a naturally occurring elemental form of oxygen. It is formednaturally in the environment or artificially with an ozone generator. Inthe atmosphere, ozone is produced in nature by UV light from the sun orhigh-voltage electric discharges from lightening. Ozone can also beartificially induced by passing an electric field through a curtain ofoxygen gas. See, Broder, Bryant C. and Jason Simon. Understanding Ozone.Materials Management in Health Care. September 2004. Ozone can also beproduced by passing air or oxygen gas through UV light at approximately185 nm wavelength, though to a significantly lower effect than with anelectric field or corona discharge. The use of ozone sterilizationtechnology was approved by the FDA in 2003. In its application forlow-temperature sterilization, ozone is produced using medical-gradeoxygen which is stimulated by electricity in a deep vacuum within asterilization chamber. This reaction causes the ozone molecule to revertback to its diatomic state by releasing an extra oxygen atom whichattaches to micro-organisms and oxidizes proteins and enzymes whichresult in the death of the organic matter. Since ozone can be convertedback into oxygen and water vapor, which can be safely vented, thismethod provides a sound and economical sterilization process. One novelapproach to sterilization technology employs ultrasonic cavitationaugmented by injected ozone of high concentration. By varying thetemperature of the water bath and the concentration of ozone subjectedto a continuous or periodic ultrasound source, it is possible toincrease the effectiveness of this application for reducingmicrobiological pollution. See, Krasnyj, V. V. et al. Sterilization ofMicroorganisms by Ozone and Ultrasound. PLASMA 2007, edited by H. J.Hartfuss et al. American Institute of Physics. 2008. Another originalapplication of ozone in a sterilization process uses ultrasoniclevitation energy and ozone bubbles to remove particles from soiledmaterials, which are then treated with silver electrolysis to killmicrobes. Micro-organisms have a bi-phospholipid layer which can onlyfunction properly in a specific conformation maintained by the disulfidebond —S—S—. Silver ions or atoms produced by silver electrolysis disruptthe bond between —S—S— and —SAg, interfering with the conformation,which then inhibit the respiration or nutrition of aerobic organisms,and thereby produce microbial inactivity. See, Ueda, Toyotoshi, et al.Simultaneous Treatment of Washing, Disinfection and Sterilization UsingUltrasonic Levitation, Silver Electrolysis and Ozone Oxidation.Biocontrol Science, Vol. 14, No. 1, pages 1-12. 2009. Ozonated water iscreated by either injecting ozone gas into water, or by exposingoxygenated water to UV light at approximately 185 nm wavelength. Ozonein water as dilute as 1 ug/ml is anti-microbial, and can be used tosterilize. Plasma-activated water (PAW) is a plasmachemical solutionobtained by the activation of water with electric discharges such ascold atmospheric plasma (CAP). PAW has been shown to significantlyreduce microbial populations and even overcome the antibiotic resistanceof bacteria when used in combination with antibiotics.

Using chemical compounds produced by the immune system, such assuperoxide and hypochlorous acid, can prove to be useful because oftheir effectiveness and known compatibility with biological processes.Superoxide is a compound that contains the highly reactive oxygenradical O₂ ⁻ and is used for oxygen-dependent killing mechanisms ofmicroorganisms in the immune system. Hypochlorous acid is an acid and anoxidizer that can be created by the immune system with the chemicalformulation HClO. Hypochlorous acid and its sodium hypochlorite NaClOand calcium hypochlorite Ca(ClO)₂ variations are used as effectivedisinfectants.

Hydrogen peroxide gas plasma also offers a fast, nontoxic alternative toEtO sterilization. One commercial application vaporizes an aqueoussolution of hydrogen peroxide in a deep vacuum chamber. Once the gaseoushydrogen peroxide is diffused throughout the load, the chamber pressureis reduced and this produces the low-temperature gas plasma. Radiationenergy in the range of radio frequency (RF) wavelength is applied to thechamber using an RF amplifier, and this induces a plasma state whichproduces reactive species that inactivate microbes. Once the high-energyspecies stop reacting, they recombine to form harmless water vapor,oxygen, and other nontoxic byproducts. See, Slaybaugh, RaeAnn.Sterilization: Gas Plasma, Steam, and Washer-Decontamination.http://infectioncontroltoday.com. Virgo Publishing. Jun. 1, 2000.

Possibly the simplest sterilization technique is to remove allmicro-organisms from a fluid. Various fluid filtration methods have beenutilized with varying degrees of filtration. A High EfficiencyParticulate Air (HEPA) filter is generally defined as being capable ofremoving 99.97% of all particulates greater than 0.3 microns. Moresophisticated filters such as Ultra Low Penetration Air (ULPA) filtersare capable of removing 99.999% of all particulates and microorganismsof the most penetrating particle size at a specified air velocity. SuperULPA filters are capable of removing 99.9999% of all particulates andmicroorganisms on the same basis as the ULPA filters. Multi-stagesterile gas filters designed for filtering compressed or pressurizedgases are capable of filtering 99.999+% at 0.01 microns (BalstonFilters, Haverhill, Mass.). The smallest know living bacteria have asize of approximately 200 nm (0.2 microns), where the smallest knownvirus has a size of approximately 12 nm (0.012 microns), so it isimportant to select an appropriately rated filter to adequately removebacteria and viruses from the media.

An alternative method for removing micro-organisms from a fluid involvesthe use of negative air ionization. This approach uses an electrostaticspace charge system (ESCS) to create negatively charged airborneparticles which may be collected onto special grounded collector platesor screens. The ESCS was observed to reduce biofilms on stainless steelsurfaces by transferring a strong negative electrostatic charge tobacterial cells on exposed areas. See, Arnold, J. and B. W. Mitchell.Use of Negative Air Ionization for Reducing Microbial Contamination onStainless Steel Surfaces. Journal of Applied Poultry Research, Vol. 11,pages 179-186. Poultry Science Association. 2002. One disadvantage tousing negative air ionization involves the accumulation of potentiallyinfectious particles onto adjacent surfaces or grounded parts of theionizer, creating a “black-wall effect” observed on the discolored wallsof the ionizer chamber. This problem may be alleviated, however, usinglocalized grounded collecting plates.

Another potential downside in using ionizers is their ability to producestatic charge which may interfere with medical equipment, though thisexposure is minimal beyond a distance of 1 meter from the ionizer. See,Escombe, A. Roderick et al. Upper-Room Ultraviolet Light and NegativeAir Ionization to Prevent Tuberculosis Transmission. PLoS Medicine(Public Library of Science). Vol. 6, Issue 3, March 2009.

Attempts have been made and disclosed to reduce HAI's by applying manyof the aforementioned sterilization techniques to sterile sites. Forexample U.S. Pat. No. 6,283,986 relates to the method of treating woundswith UV radiation.

U.S. Patent Publication No. 2010/0234794 relates to a system and methodfor reducing surgical site infection by delivering air to the surgicalsite and incorporating anti-microbial agents and optionally UV or bluelight.

U.S. Patent Publication No. 2008/0161749 relates to a portable infectioncontrol device that creates an environment around an open woundcontaining sterile gas.

U.S. Patent Publication No. 2010/0280436 relates to an apparatus andmethod for reducing contamination of surgical sites by providing alaminar flow of sterile gas across the surgical site in order to preventambient airborne particles from entering the site.

U.S. Patent Publication No. 2009/0054853 relates to a system that formsa sterile gas barrier to prevent airborne contaminant from reaching thesite, and where light is emitted to activate a therapeutic agent in thegas.

U.S. Pat. No. 6,513,529 relates to the method for excluding infectiousagents from the site of an incision by repelling the electrostaticallycharged infectious agents.

U.S. Patent Publication No. 1991/5037395 relates to a system used toheat a medical device to an elevated temperature where bacteria cannotsurvive.

U.S. Pat. No. 5,037,395 relates to a catheter for suppressing tunnelinfection by raising the temperature.

U.S. Patent Publication No. 2009/0143718 relates to a plasma treatmentprobe, which applies non-thermal plasma to a patient's body to treat aregion.

U.S. Patent Publication No. 2008/0017564 relates to an apparatus used toremove particulates from a flowing fluid using magnetic attraction andrepulsion.

U.S. Patent Publication No. 2010/0268249 relates to a system used tocreate a sterile barrier while still permitting the use of medicalinstruments on the surgical site.

U.S. Patent Publication No. 2004/6733435 relates a system and methodused to treat an infection and other conditions of a lesion with amagnetic field.

U.S. Pat. No. 5,154,165 relates a device and method used to reduceinfection in a patient's body by generating an electric field.

U.S. Pat. No. 6,254,625 relates a device used to reduce infection bysanitizing hands.

U.S. Patent Application No. 2010/0222852 relates an apparatus and methodused to reduce infection by decolonizing microbes on the surfaces of theskin and in body cavities.

U.S. Patent Application No. 2010/0266446 relates an apparatus used toreduce infection by sanitizing the hands and forearms.

U.S. Pat. No. 8,318,090 relates a system and method used to reduceinfection by sanitizing the hands.

U.S. Pat. No. 6,254,625 relates an apparatus and method used to reduceinfection by sanitizing the hands.

U.S. Pat. No. 8,142,713 relates a system and method used to reduceinfection by sanitizing the hands.

Accordingly, each of the aforementioned inventions has limitations andthere is still a need for novel apparatuses, systems, and methods forreducing healthcare acquired infections by preventing infectious agentsat the sterile site.

SUMMARY OF THE INVENTION

This invention provides an apparatus configured to reduce infectiousagents at a sterile site in order to reduce the incidence of ahealthcare associated infections and disease. Therefore, an apparatus,system, and method are disclosed that utilize one or more of theaforementioned methods of preventing infectious agents from coming incontact with the sterile site while protecting the sterile site and theuser from the potential negative effects of these methods.

In one aspect, the invention provides an apparatus for creating aninfectious agent barrier for a sterile site. The apparatus has a housingthat defines an opening for access of an object to the sterile site andat least one emitter of electromagnetic radiation coupled to thehousing. The emitter is positioned to direct electromagnetic radiationinto the opening defined by the housing and is configured to create afield of electromagnetic radiation across the opening that issubstantially free of voids, so when an object passes through theopening, the outer perimeter of the object intersects the field. Theapparatus can have at least three emitting points. The apparatus canhave a housing that completely surrounds the sterile site with nointerruptions. The apparatus of claim can have a housing that isconfigured as a surgical retractor. The housing can be configured tocreate the opening by holding the skin and tissue. The apparatus canhave electromagnetic radiation that is ultra violet radiation with awavelength between 200 and 280 nm. The electromagnetic radiation can beultraviolet radiation that has a mean wavelength of 260 nm+/−10 nm. Theelectromagnetic radiation can be ultraviolet radiation that has aminimum energy level of 6000 microwatts per second per squarecentimeter. The ultra violet radiation can be produced by light emittingdiodes. The apparatus can have electromagnetic radiation field that iscoherent. The coherent electromagnetic radiation field can be defined asa plane. The apparatus can have electromagnetic radiation that is anelectric field. The electromagnetic radiation can be an electric fieldthat is alternating. The electromagnetic radiation can be an electricfield that is high frequency. The electromagnetic radiation can be anelectric field that has a frequency between 5 Mhz and 20 Mhz. Theelectromagnetic radiation can be an electric field that has a frequencyof 10 Mhz+/−2 Mhz. The apparatus can have a housing that is shielded.The apparatus can have an electromagnetic radiation field that isactivated by a sensor. The electromagnetic radiation can have a sensorthat is activated when an object in proximity to the sterile site issensed. The electromagnetic radiation can have a sensor that isactivated based on a condition change at the sterile site. Theelectromagnetic radiation can have a sensor that is activated when anobject intersects the opening in the sterile site. The apparatus can beconfigured where the opening is a lumen. The apparatus can be configuredwhere the sterile site is a surgical site. The apparatus can beconfigured where the surgical site is a surgical incision. The apparatuscan be configured where the surgical incision is for placement of aCIED. The apparatus can be configured where the sterile site is asterile field. The apparatus can be configured where the sterile site isa hood. The apparatus can be configured where the sterile site is awound. The apparatus can be configured where the sterile site is acatheter. The sterile site can be configured where the catheter is acentral line, dialysis, PICC, port, foley, ventilator, pacing lead, orfeeding tube. The apparatus can be configured where the sterile site isa luer. The sterile site can be configured where the luer is a swabbableluer. The apparatus can be configured where the sterile site is afitting. The apparatus can be configured where the sterile site is ahub. The apparatus can be configured where the sterile site is a tubingline. The apparatus can be configured where the EMR is plasma. Theapparatus can be configured where the EMR is an electron beam. Theapparatus can be configured where the object includes one or more of aninstrument, a device, and an appendage of a medical professional.

In another aspect the invention provides a sterile site in a living bodythat has an inner and outer diameter, and a longitudinal length. Theinvention also has an apparatus for creating an infectious agent barrierfor a length of the sterile site, the apparatus has a housing with awidth and has an opening partially surrounding the sterile site. Thehousing has at least one emitter of energy coupled to the housing, andthe emitter is positioned to direct energy into the opening defined bythe housing and is configured to create a field of energy around thesterile site that is substantially free of voids and has a length longerthan its width, so that a portion of the inner and outer diameter andlength of the sterile site intersects the field. The apparatus can beconfigured where the energy is in the form of heat. The energy can beconfigured where the heat is generated by an exothermic reaction. Theapparatus can be configured where the energy is an electric field. Theapparatus can be configured where the energy is a combination of heatand an electric field. The apparatus can be configured where the energyis electromagnetic radiation. The energy can be electromagneticradiation that is ultraviolet light. The apparatus can be configuredwhere the sterile site is a catheter. The sterile site can be a catheterthat is a central line, dialysis, PICC, port, foley, ventilator, pacinglead, or feeding tube.

In yet another aspect, the invention provides an apparatus for creatingan infectious agent barrier for a sterile site. The apparatus has ahousing with an inner perimeter surface and an outer perimeter surface.The inner perimeter surface has an opening for access of an object tothe sterile site. The outer perimeter surface creates a barrier for thesterile site. There is at least one emitter of energy coupled to thehousing, and the emitter is positioned to direct energy into the barrierdefined by the housing and is configured to create a field of energyaround the barrier that is substantially free of voids, so that aninfectious agent in proximity to the barrier intersects the field. Theapparatus can be configured where the housing's inner perimeter surfaceis substantially convex. The apparatus can be configured where thehousing's outer perimeter surface is substantially concave. Theapparatus can be configured as a surgical wound retractor. The housingcan be configured where the surgical wound retractor is malleable. Theapparatus can be configured where the energy is in the form of heat. Theenergy can be heat that is generated by an exothermic reaction. Theapparatus can be configured where the energy is an electric field. Theapparatus can be configured where the energy is a combination of heatand an electric field. The apparatus can be configured where the energyis electromagnetic radiation. The apparatus can have a housing thatcontains a heat conductive material. The apparatus can have a housingthat contains an antimicrobial coating. The apparatus can be configuredwhere the energy is an electric charge. The energy can be an electriccharge that is a positive charge. The energy can be an electric chargethat is a negative charge. The apparatus can be configured where theenergy is pressurized gas. The energy can be pressurized gas that issterile air. The energy can be pressurized gas that is CO2. Theapparatus can be configured where the housing is elastic and configuredto close the opening into the sterile site.

In still yet another aspect, the invention provides a system forcreating an infectious agent barrier for a sterile site. The system hasa luer activated port in fluid communication with a living body and hasan internal surface and external luer thread. The system also includes asterile site apparatus that has a housing configured to mate with theexternal luer thread of the luer activated port. The housing has atleast one emitter of electromagnetic radiation and one sensor coupled tothe housing, so that the sterile site apparatus can create a field ofelectromagnetic radiation that is substantially free of voids over theinternal surface and external luer threads of the luer activated portwhen the sensor detects that the sterile site apparatus is mated to theluer activated port. The system can be configured where theelectromagnetic radiation is ultra violet radiation with a wavelengthbetween 200 and 280 nm. The electromagnetic radiation can be ultravioletradiation that has a mean wavelength of 260 nm+/−10 nm. Theelectromagnetic radiation can be ultraviolet radiation that has aminimum energy level of 6000 microwatts per second per squarecentimeter. The ultra violet radiation can be produced by light emittingdiodes.

A system is also provided for creating an infectious agent barrier for asterile site, the system comprising a surgical retractor in contact witha living body having an internal and external surface; and a sterilesite apparatus having a housing configured to mate with the internalsurface of the surgical retractor, the housing having at least oneemitter of energy coupled to the housing; whereby the sterile siteapparatus creates a field of energy that is substantially free of voidsover the internal and external surfaces of the surgical retractor. Thesystem can be configured where the energy is in the form of heat. Theenergy can be heat that is generated by an exothermic reaction.

In still yet another aspect, the invention provides a system forcreating an infectious agent barrier for a sterile site. The system hasa surgical retractor in contact with a living body that has an internaland external surface. The system also includes a sterile site apparatusthat has a housing configured to mate with the internal surface of thesurgical retractor. The housing has at least one emitter of energycoupled to the housing so that the sterile site apparatus can create afield of energy that is substantially free of voids over the internaland external surfaces of the surgical retractor. The system can beconfigured where the energy is in the form of heat. The energy can beheat that is generated by an exothermic reaction.

In still yet another aspect, the invention provides a method of creatingan infectious agent barrier for a sterile site. The method includescoupling at least one emitter from a list of 1) electromagneticradiation, 2) electrical field, and 3) heat to a housing that has anopening for access of an object to the sterile site. The method alsoincludes positioning said emitter to direct the electromagneticradiation, electrical field, or heat into the opening defined by thehousing. The method further includes configuring the emitter to create afield of electromagnetic radiation, electrical field, or heat across theopening that is substantially free of voids. The method further includespassing an object through the opening, so that the outer perimeter ofthe object intersects the field. The method can include where theelectromagnetic radiation is ultra violet radiation with a wavelengthbetween 200 and 280 nm. The electromagnetic radiation can be ultravioletradiation that has a mean wavelength of 260 nm+/−10 nm. Theelectromagnetic radiation can be ultraviolet radiation that has aminimum energy level of 6000 microwatts per second per squarecentimeter. The ultra violet radiation can be produced by light emittingdiodes. The method can include where the electric charge is a negativecharge. The method can further include where the electric charge is apositive charge. The method can further include where the pressurizedgas is sterile air.

The method can further include where the pressurized gas is CO2. Themethod can further include where the heat is generated by an exothermicreaction. The method can further include where the housing is configuredas a surgical retractor

According to another aspect of this invention, an apparatus is providedfor creating an electromagnetic radiation barrier for a sterile site,whereby infectious agents are inhibited from entering the sterile site.The apparatus includes a housing defining an unobstructed passageconfigured to receive an object, the passage having a proximal inlet anda distal outlet; at least one emitter of electromagnetic radiationcoupled to the housing, the at least one emitter being positioned todirect electromagnetic radiation into the passage defined by the housingand being configured to create a substantially void free barrier ofelectromagnetic radiation extending across the passage; the barrier ofelectromagnetic radiation having a proximal extent, a distal extent, anda depth defined by the distance between the proximal extent and thedistal extent, whereby an outer perimeter of the object does notintersect the barrier when the entire object is proximal to the proximalinlet of the passage or distal to the distal outlet of the passage andintersects the barrier when the object passes through the proximal inletto the distal outlet; the barrier creating a substantially void freeintersection of electromagnetic radiation with the object perimetercorresponding to the depth of the barrier as the object passes betweenthe proximal inlet and distal outlet of the passage. According to stillanother aspect of the invention, a sterile site apparatus is providedfor creating an electromagnetic radiation barrier, whereby infectiousagents are inhibited from entering the sterile site. The apparatusincludes a housing defining an unobstructed proximal opening configuredto receive an object and an unobstructed distal opening configured toreceive an object; at least one emitter of electromagnetic radiationcoupled to the housing, the at least one emitter being positioned todirect electromagnetic radiation into a passage extending between theproximal and distal openings defined by the housing and being configuredto create a substantially void free barrier of electromagnetic radiationextending across the passage; means for limiting proximal and distalextents of the barrier of electromagnetic radiation to remain within thepassage between the proximal and distal openings defined by the housingwhereby an outer perimeter of the object does not intersect the barrierwhen the entire object is proximal to the proximal opening or distal tothe distal opening; and the barrier creating a substantially void freeintersection of electromagnetic radiation with the object perimeter asthe object passes through the passage between the proximal and distalopenings defined by the housing of the sterile site apparatus. Accordingto another aspect of the invention, a system is provided for inhibitinginfectious agents on an object from entering a sterile site. The systemincludes a barrier generation means for generating a substantially voidfree barrier that inhibits the infectious agents from entering thesterile site by intersecting a perimeter of the object and remainingsubstantially void free upon the intersection of the barrier with theperimeter of the object; a sensor positioned to sense at least one ofinfectious agents, the object, ambient surroundings of the sterile site,and the barrier generated by the barrier generation means; and a controlsystem coupled to the barrier generation means and to the sensor, thecontrol system being configured to receive conditions sensed by thesensor and to activate the barrier generation means to generate thebarrier.

A method for inhibiting infectious agents on an object from entering asterile site is provided according to yet another aspect of theinvention. The method includes positioning a barrier generation meansfor generating a substantially void free barrier such that the barrierinhibits the infectious agents from entering the sterile site byintersecting a perimeter of the object and remains substantially voidfree upon the intersection of the barrier with the perimeter of theobject; sensing at least one of infectious agents, the object, ambientsurroundings of the sterile site, and the barrier generated by thebarrier generation means; and activating the barrier generation means togenerate the barrier in response to conditions sensed by the sensor.

The disclosure and its various embodiments can now be better understoodby turning to the following detailed description of the embodimentswhich are presented as illustrated examples of aspects of the invention.It is expressly understood that the claims are not limited by theillustrated embodiments described below.

BRIEF DESCRIPTION OF THE DRAWINGS

The apparatuses and their advantages will be understood more fully fromthe following description of the figures where:

FIG. 1 is a diagram describing the features and systems used by anembodiment of a sterile site apparatus.

FIG. 2 is a diagram describing the features and systems of an embodimentof a gas handling unit.

FIG. 3 is a pictorial view illustration of an embodiment of a sterilesite apparatus.

FIG. 4 is a top view illustration of an embodiment of a vacuum headpositioned above the sterile site apparatus and sterile site.

FIG. 5 is a cross-sectional view illustration of the vacuum head andsterile site apparatus of FIG. 4 while the vacuum head is removinginfectious agent containing air surrounding the sterile site.

FIG. 6 is a top view illustration of the vacuum head positioned aboveand at an angle to the sterile site apparatus and sterile site.

FIG. 7 is a cross-sectional view illustration of the vacuum head andsterile site apparatus of FIG. 6 while the vacuum head is removinginfectious agent containing air surrounding the sterile site.

FIG. 8 is a top view illustration of an embodiment of a collapsiblevacuum head attached near the sterile site using suction.

FIG. 9 is a cross-sectional view illustration of the collapsible vacuumhead of FIG. 8 while it is removing infectious agent containing airsurrounding the sterile site.

FIG. 10 is a top view illustration of the collapsible vacuum headattached near the sterile site using two grip pads.

FIG. 11 is a cross-sectional view illustration of the collapsible vacuumhead of FIG. 10 while it is removing infectious agent containing airsurrounding the sterile site.

FIG. 12 is a top view illustration of the collapsible vacuum headattached near the sterile site using two oppositely charged magneticpads.

FIG. 13 is a cross-sectional view illustration of the collapsible vacuumhead of FIG. 12 while it is removing infectious agent containing airsurrounding the sterile site.

FIG. 14 is a pictorial view illustration of an embodiment of a deflatedvacuum tube.

FIG. 15 is a pictorial view illustration of the inflated vacuum tube.

FIG. 16 is a pictorial view illustration of the inflated vacuum tubewith semi-rigid insertion card.

FIG. 17 is a side view illustration of the inflated vacuum tube withsemi-rigid insertion card.

FIG. 18 is a rear view illustration of the inflated vacuum tube withsemi-rigid insertion card.

FIG. 19 is a top view illustration of an embodiment of a sterile siteapparatus positioned above the sterile site.

FIG. 20 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 19 while its gas release openings release gas mixturesto displace infectious agent containing air.

FIG. 21 is a pictorial view illustration of the sterile site apparatusthat allows gas mixtures to be released in various directions.

FIG. 22 is a top view illustration of the sterile site apparatus of FIG.21.

FIG. 23 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 22 while its gas release openings release a gasmixture in various directions to displace infectious agent containingair.

FIG. 24 is a top view illustration of an embodiment of a sterile siteapparatus positioned above the sterile site.

FIG. 25 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 24 while its gas release openings release a gasmixture to prevent infectious agent containing air from flowing underthe housing of the sterile site apparatus.

FIG. 26 is a top view illustration of an embodiment of a sterile siteapparatus positioned above the sterile site.

FIG. 27 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 26 while it forms a disinfecting fluid barrier createdby the fluid release openings.

FIG. 28 is an enlarged view illustration of the sterile site apparatusof FIG. 27 highlighting the use of multiple lumens containing variousfluids and materials.

FIG. 29 is an enlarged view illustration of the sterile site apparatusof FIG. 28 highlighting a method used by the fluid release openings formixing several fluids and materials.

FIG. 30 is a top view illustration of an embodiment of a sterile siteapparatus before it creates an extended fluid barrier over the sterilesite.

FIG. 31 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 30.

FIG. 32 is a top view illustration of the sterile site apparatus afterit creates an extended fluid barrier over the sterile site.

FIG. 33 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 32.

FIG. 34 is a top view illustration of the sterile site apparatus whilean object passes through the extended fluid barrier.

FIG. 35 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 34.

FIG. 36 is a top view illustration of an embodiment of a sterile siteapparatus before it creates a planar fluid barrier over the sterilesite.

FIG. 37 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 36.

FIG. 38 is a top view illustration of the sterile site apparatus afterit creates a planar fluid barrier over the sterile site.

FIG. 39 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 38.

FIG. 40 is a top view illustration of the sterile site apparatus whilean object passes through the planar fluid barrier.

FIG. 41 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 40.

FIG. 42 is a top view illustration of an embodiment of a sterile siteapparatus before it creates an extended solid barrier over the sterilesite.

FIG. 43 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 42.

FIG. 44 is a top view illustration of the sterile site apparatus whileit creates an extended solid barrier over the sterile site.

FIG. 45 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 44.

FIG. 46 is a top view illustration of the sterile site apparatus afterit creates an extended solid barrier over the sterile site.

FIG. 47 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 46.

FIG. 48 is a top view illustration of an embodiment of a sterile siteapparatus before it creates a planar solid barrier over the sterilesite.

FIG. 49 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 48.

FIG. 50 is a top view illustration of the sterile site apparatus whileit creates a planar solid barrier over the sterile site.

FIG. 51 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 50.

FIG. 52 is a top view illustration of the sterile site apparatus afterit creates a planar solid barrier over the sterile site.

FIG. 53 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 52.

FIG. 54 is a top view illustration of an embodiment of a sterile siteapparatus before it creates a thin-film solid barrier over the sterilesite.

FIG. 55 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 54.

FIG. 56 is a top view illustration of the sterile site apparatus whileit creates a thin-film solid barrier over the sterile site.

FIG. 57 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 56.

FIG. 58 is a top view illustration of the sterile site apparatus afterit creates a thin-film solid barrier over the sterile site.

FIG. 59 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 58.

FIG. 60 is a pictorial view illustration of an embodiment of anattachable solid barrier before it is attached to the sterile siteapparatus.

FIG. 61 is a pictorial view illustration of the attachable solid barrierafter it is attached to the sterile site apparatus.

FIG. 62 is a pictorial view illustration of the sterile site apparatuswhile an object passes through the attachable solid barrier.

FIG. 63 is a pictorial view illustration of the sterile site apparatusafter the attachable solid barrier has separated from itself and leftthe object undisturbed.

FIG. 64 is a pictorial view illustration of the sterile site apparatusafter the attachable solid barrier has been removed from the sterilesite apparatus and left the object undisturbed.

FIG. 65 is a pictorial view illustration of an embodiment of anattachable thin-film solid barrier before it is attached to the sterilesite apparatus.

FIG. 66 is a pictorial view illustration of the attachable thin-filmsolid barrier after it is initially attached and begins to be applied tothe sterile site apparatus.

FIG. 67 is a pictorial view illustration of the attachable thin-filmsolid barrier as it continues to be applied to the sterile siteapparatus.

FIG. 68 is a pictorial view illustration of the attachable thin-filmsolid barrier after it is fully attached to the sterile site apparatus.

FIG. 69 is a pictorial view illustration of the sterile site apparatusas an object passes through the attachable thin-film solid barrier.

FIG. 70 is a pictorial view illustration of an embodiment of a sterilesite apparatus before the opening/closing feature is used.

FIG. 71 is a pictorial view illustration of the sterile site apparatuswhile the opening/closing feature is used to reduce the size of theopening leading to the sterile site and seal around an object in contactwith the sterile site.

FIG. 72 is a pictorial view illustration of the sterile site apparatusafter the opening/closing feature is used to reduce the size of theopening leading to the sterile site and seal around an object in contactwith the sterile site.

FIG. 73 is a pictorial view illustration of an embodiment of a sterilesite apparatus emitting an EMR barrier.

FIG. 74 is a top view illustration of the sterile site apparatusdemonstrating its ability to expose a portion of an object's exteriorsurface to EMR even when multiple objects are simultaneously enteringthe EMR barrier.

FIG. 75 is a top view illustration of the sterile site apparatusdemonstrating its ability to expose a portion of an object's exteriorsurface to EMR even when multiple objects are simultaneously enteringthe EMR barrier.

FIG. 76 is a top view illustration of the sterile site apparatusdemonstrating its ability to expose a portion of an object's exteriorsurface to EMR even when multiple objects are simultaneously enteringthe EMR barrier.

FIG. 77 is a cross-sectional view illustration of an embodiment of asterile site apparatus to show that a coherent EMR barrier composed ofconvergent beams of EMR can be formed by using a lens in conjunctionwith EMR emitted from a point source EMR emitter.

FIG. 78 is a cross-sectional view illustration of an embodiment of asterile site apparatus to show that a coherent EMR barrier composed ofparallel beams of EMR can be formed by using a lens in conjunction withEMR emitted from a point source EMR emitter.

FIG. 79 is a cross-sectional view illustration of an embodiment of asterile site apparatus to show that a coherent EMR barrier composed ofconvergent beams of EMR can be formed by using a lens in conjunctionwith EMR emitted from a line source EMR emitter.

FIG. 80 is a cross-sectional view illustration of an embodiment of asterile site apparatus to show that a coherent EMR barrier composed ofparallel beams of EMR can be formed by using a lens in conjunction withEMR emitted from a line source EMR emitter.

FIG. 81 is a top view illustration of an embodiment of a sterile siteapparatus showing the effect of using a reflective surface to enhancethe transmission of EMR.

FIG. 82 is a top view illustration of an embodiment of a sterile siteapparatus showing how the desired wavelength(s) of EMR can be pulsedfrom multiple locations at a given time interval.

FIG. 83 is a top view illustration of the sterile site apparatus of FIG.82 showing how the desired wavelength(s) of EMR can be pulsed frommultiple different locations at a given time interval.

FIG. 84 is a top view illustration of the sterile site apparatus of FIG.83 showing how the desired wavelength(s) of EMR can be pulsed frommultiple locations at a given time interval.

FIG. 85 is a top view illustration of an embodiment of a sterile siteapparatus showing how an EMR emitter can create a sweeping motion withthe desired wavelength(s) of EMR.

FIG. 86 is a top view illustration of the sterile site apparatus of FIG.85 showing how an EMR emitter can create a sweeping motion with thedesired wavelength(s) of EMR.

FIG. 87 is a top view illustration of the sterile site apparatus of FIG.86 showing how an EMR emitter can create a sweeping motion with thedesired wavelength(s) of EMR.

FIG. 88 is an illustration of how an EMR filter can be used to yieldonly the desired wavelength(s) of EMR.

FIG. 89 is an illustration of how an EMR reflector can be used to yieldonly the desired wavelength(s) of EMR.

FIG. 90 is an illustration of how an emission material can be used toemit the desired wavelength(s) of EMR.

FIG. 91 is an illustration of how an EMR amplifier can be used toamplify the desired wavelength(s) of EMR.

FIG. 92 is an illustration of how a coating can be used on the surfaceof an object.

FIG. 93 is a top view illustration of an embodiment of a line sourcetoroid convex lens apparatus, which uses a line source EMR emitter and atoroid convex lens to create an EMR barrier.

FIG. 94 is a cross-sectional view illustration of the line source toroidconvex lens apparatus of FIG. 93.

FIG. 95 is a top view illustration of an embodiment of a point sourcetoroid convex lens apparatus, which uses point source EMR emitters and atoroid convex lens to create an EMR barrier.

FIG. 96 is a cross-sectional view illustration of the point sourcetoroid convex lens apparatus of FIG. 95.

FIG. 97 is a top view illustration of an embodiment of a line sourcetoroid meniscus lens apparatus, which uses a line source EMR emitter anda toroid meniscus lens to create an EMR barrier.

FIG. 98 is a cross-sectional view illustration of the line source toroidmeniscus lens apparatus of FIG. 97.

FIG. 99 is a top view illustration of an embodiment of a point sourcetoroid meniscus lens apparatus, which uses point source EMR emitters anda toroid meniscus lens to create an EMR barrier.

FIG. 100 is a cross-sectional view illustration of the point sourcetoroid meniscus lens apparatus of FIG. 99.

FIG. 101 is a top view illustration of an embodiment of a line sourcetoroid plano-convex lens apparatus, which uses a line source EMR emitterand a toroid plano-convex lens to create an EMR barrier.

FIG. 102 is a cross-sectional view illustration of the line sourcetoroid plano-convex lens apparatus of FIG. 101.

FIG. 103 is a top view illustration of an embodiment of a point sourcetoroid plano-convex lens apparatus, which uses point source EMR emittersand a plano-toroid convex lens to create an EMR barrier.

FIG. 104 is a cross-sectional view illustration of the point sourcetoroid plano-convex lens apparatus of FIG. 103.

FIG. 105 is a top view illustration of an embodiment of a line sourcemultiple partial-toroid convex lens apparatus, which uses a line sourceEMR emitter and multiple partial-toroid convex lens to create an EMRbarrier.

FIG. 106 is a cross-sectional view illustration of the line sourcemultiple partial-toroid convex lens apparatus of FIG. 105.

FIG. 107 is a top view illustration of an embodiment of a point sourcemultiple partial-toroid convex lens apparatus, which uses point sourceEMR emitters and multiple partial-toroid convex lens to create and EMRbarrier.

FIG. 108 is a cross-sectional view illustration of the point sourcemultiple partial-toroid convex lens apparatus of FIG. 107.

FIG. 109 is a top view illustration of an embodiment of a line sourcemultiple partial-toroid meniscus lens apparatus, which uses a linesource EMR emitter and multiple partial-toroid meniscus lens to createan EMR barrier.

FIG. 110 is a cross-sectional view illustration of the line sourcemultiple partial-toroid meniscus lens apparatus of FIG. 109.

FIG. 111 is a top view illustration of an embodiment of a point sourcemultiple partial-toroid meniscus lens apparatus, which uses point sourceEMR emitters and multiple partial-toroid meniscus lens to create an EMRbarrier.

FIG. 112 is a cross-sectional view illustration of the point sourcemultiple partial-toroid meniscus lens apparatus of FIG. 111.

FIG. 113 is a top view illustration of an embodiment of a line sourcemultiple partial-toroid plano-convex lens apparatus, which uses a linesource EMR emitter and multiple partial-toroid plano-convex lens tocreate an EMR barrier.

FIG. 114 is a cross-sectional view illustration of the line sourcemultiple partial-toroid plano-convex lens apparatus of FIG. 113.

FIG. 115 is a top view illustration of an embodiment of a point sourcemultiple partial-toroid plano-convex lens apparatus, which uses pointsource EMR emitters and multiple partial-toroid plano-convex lens tocreate an EMR barrier.

FIG. 116 is a cross-sectional view illustration of the point sourcemultiple partial-toroid plano-convex lens apparatus of FIG. 115.

FIG. 117 is a side view illustration of an embodiment of a sterile siteapparatus.

FIG. 118 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 117 to show the distribution of fiber opticsthroughout the housing.

FIG. 119 is a side view illustration of an embodiment of a sterile siteapparatus.

FIG. 120 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 119 to show the distribution of internal EMR emittersinside the housing.

FIG. 121 is a top view illustration of an embodiment of a sterile siteapparatus.

FIG. 122 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 121.

FIG. 123 is an enlarged view illustration of the sterile site apparatusof FIG. 122 to show how the desired wavelengths of EMR can betransmitted through a medium and towards the sterile site by usingreflective surfaces.

FIG. 124 is a pictorial view illustration of an embodiment of a sterilesite apparatus highlighting its ability to be molded into a desiredshape.

FIG. 125 is a top view illustration of the sterile site apparatus ofFIG. 124 while it emits an EMR barrier composed of the desiredwavelengths of EMR.

FIG. 126 is a pictorial view illustration of the sterile site apparatusand its internal features.

FIG. 127 is an enlarged view illustration of the sterile site apparatusof FIG. 126 highlighting its internal features.

FIG. 128 is a pictorial view illustration of an embodiment of a sterilesite apparatus with housing links connected to each other to form aflexible linked structure for the housing.

FIG. 129 is a top view illustration of the sterile site apparatus ofFIG. 128 with the addition of the EMR barrier being emitted.

FIG. 130 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a cooling unit and a single EMR emitter located upagainst the housing.

FIG. 131 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a cooling unit, an object sensor and a single EMRemitter located up against the housing.

FIG. 132 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a cooling unit and a single EMR emitter, but withoutthe housing.

FIG. 133 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a cooling unit, and object sensor and a single EMRemitter, but without the housing.

FIG. 134 is a pictorial view illustration of an embodiment of a sterilesite apparatus with multiple cooling units and EMR emitters located upagainst the housing.

FIG. 135 is a pictorial view illustration of an embodiment of a sterilesite apparatus with multiple cooling units, object sensors and EMRemitters located up against the housing.

FIG. 136 is a pictorial view illustration of an embodiment of a sterilesite apparatus with multiple cooling units and EMR emitters, but withoutthe housing.

FIG. 137 is a pictorial view illustration of an embodiment of a sterilesite apparatus with multiple cooling units, object sensors, and EMRemitters, but without the housing.

FIG. 138 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a positively charged electrode to attract negativelycharged infectious agents.

FIG. 139 is a top view illustration of the sterile site apparatus ofFIG. 138.

FIG. 140 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 139 with the addition of electrons and fallinginfectious agents.

FIG. 141 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 139 once the infectious agents have become attached tothe electrons.

FIG. 142 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 139 once the negatively charged infectious agents havebecome attached to the positively charged electrode.

FIG. 143 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a negatively charged electrode to attract positivelycharged infectious agents.

FIG. 144 is a top view illustration of the sterile site apparatus ofFIG. 143.

FIG. 145 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 144 with the addition of protons and fallinginfectious agents.

FIG. 146 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 144 once the infectious agents have become attached tothe protons.

FIG. 147 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 144 once the positively charged infectious agents havebecome attached to the negatively charged electrode.

FIG. 148 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a negatively charged electrode to repel negativelycharged infectious agents.

FIG. 149 is a top view illustration of the sterile site apparatus ofFIG. 148.

FIG. 150 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 149 with the addition of electrons and fallinginfectious agents.

FIG. 151 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 149 once the infectious agents have become attached tothe electrons.

FIG. 152 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 149 once the negatively charged infectious agents havebeen repelled by the negatively charged electrode.

FIG. 153 is a pictorial view illustration of an embodiment of a sterilesite apparatus with a positively charged electrode to repel positivelycharged infectious agents.

FIG. 154 is a top view illustration of the sterile site apparatus ofFIG. 153.

FIG. 155 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 154 with the addition of protons and fallinginfectious agents.

FIG. 156 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 154 once the infectious agents have become attached tothe protons.

FIG. 157 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 154 once the positively charged infectious agents havebeen repelled by the positively charged electrode.

FIG. 158 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 159 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 158 with the addition of ozone-generating EMR beingemitted into the sterile site to create ozone gas, which is revertedback to oxygen gas as it leaves the sterile site due to contact with theEMR barrier.

FIG. 160 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 161 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 160 with the addition of sterile gas being pumped intothe sterile site to create a positive pressure region.

FIG. 162 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 163 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 162 with the addition of ozone gas being pumped intothe sterile site, where the ozone gas is reverted back to oxygen gas asit leaves the sterile site due to contact with the EMR barrier.

FIG. 164 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 165 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 164 with the addition of fluids being pumped into ornear the sterile site to form a disinfecting fluid barrier, a cloud overthe sterile site apparatus and sterile site, or a cloud between thesterile site apparatus and sterile site.

FIG. 166 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 167 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 166 with the addition of ozone-generating EMR beingpulsed in the sterile site.

FIG. 168 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 166 with the addition of ozone gas that was created byozone-generating EMR of FIG. 167.

FIG. 169 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 166 with the addition of ozone-eliminating EMR beingpulsed in the ozone-filled region of the sterile site.

FIG. 170 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 166 with the sterile site containing only sterilizedambient gases.

FIG. 171 is a pictorial view illustration of an embodiment of a sterilesite apparatus, its unbroken detecting region of the object sensor, andan object.

FIG. 172 is a pictorial view illustration of the sterile site apparatusof FIG. 171 after an object has disrupted the detecting region.

FIG. 173 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 174 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 173 highlighting the various object and sterile sitesensors.

FIG. 175 is a pictorial view illustration of an embodiment of a visiblelight detection system when no visible light is blocked from enteringthe transmission structure.

FIG. 176 is a pictorial view illustration of the visible light detectionsystem when some visible light is blocked from entering the transmissionstructure by an object creating a shadow as the object travels near thesterile site.

FIG. 177 is a pictorial view illustration of the visible light detectionand EMR emission system when no visible light is blocked from enteringthe transmission structure.

FIG. 178 is a pictorial view illustration of the visible light detectionand EMR emission system when some visible light is blocked from enteringthe transmission structure by an object creating a shadow as the objecttravels near the sterile site, which causes the creation of an EMRbarrier.

FIG. 179 is a pictorial view illustration of an embodiment of a sterilesite apparatus highlighting its internal features.

FIG. 180 is an enlarged view of the sterile site apparatus of FIG. 179highlighting its internal features.

FIG. 181 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 182 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 181 displaying the location of the region of negativepressure and suction gasket used for attachment near the sterile site.

FIG. 183 is an enlarged view illustration of the sterile site apparatusof FIG. 182 highlighting the region of negative pressure and suctiongasket.

FIG. 184 is a side view illustration of an embodiment of a sterile siteapparatus with a conformable gasket before it is placed near the sterilesite.

FIG. 185 is a side view illustration of the sterile site apparatus ofFIG. 184 after the sterile site apparatus has been lowered and theconformable gasket has created a seal between the sterile site apparatusand area near the sterile site.

FIG. 186 is a pictorial view illustration of an embodiment of a sterilesite apparatus and its magnetic strip before being lowered on theoppositely charged magnetic strip surrounding the sterile site.

FIG. 187 is a top view illustration of the sterile site apparatus ofFIG. 186.

FIG. 188 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 187.

FIG. 189 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 187 after it has been lowered and the magnetic stripshave engaged.

FIG. 190 is a top view illustration of an embodiment of a sterile siteapparatus and its shield.

FIG. 191 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 190 and highlights the ability of the shield toprotect against EMR released at a potentially harmful trajectory.

FIG. 192 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 193 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 192 highlighting the ability of the retracting featureto hold back human tissue and isolate infectious agents on the exteriorsurface of human tissue.

FIG. 194 is a top view illustration of an embodiment of a sterile siteapparatus and its ergonomic attachment.

FIG. 195 is a cross-sectional view illustration of the sterile siteapparatus and its ergonomic attachment of FIG. 194.

FIG. 196 is a top view illustration of an embodiment of a sterile siteapparatus highlighting its various features.

FIG. 197 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 196 highlighting its various features.

FIG. 198 is an enlarged view illustration of the sterile site apparatusof FIG. 197 highlighting its various features.

FIG. 199 is a pictorial view illustration of an embodiment of a sterilesite apparatus before a sterile sleeve is slid onto the sterile siteapparatus.

FIG. 200 is a pictorial view illustration of the sterile site apparatusof FIG. 199 with the addition of the sterile sleeve initially being slidonto the housing of the sterile site apparatus.

FIG. 201 is a pictorial view illustration of the sterile site apparatusof FIG. 200 with the sterile sleeve continuing to be slid onto thehousing of the sterile site apparatus.

FIG. 202 is a pictorial view illustration of the sterile site apparatusof FIG. 201 with the sterile sleeve continuing to be slid onto thesupply cord of the sterile site apparatus.

FIG. 203 is a pictorial view illustration of an embodiment of a sterilesite apparatus before it is enclosed in the two sterile, rigidcomponents.

FIG. 204 is a pictorial view illustration of the sterile site apparatusof FIG. 203 after it is enclosed in the two sterile, rigid components.

FIG. 205 is a pictorial view illustration of an embodiment of a movablearm with hollow, rigid members attached to movable joints, which allowfor the desired positioning of the sterile site apparatus above thesterile site.

FIG. 206 is a pictorial view illustration of an embodiment of a sterilesite apparatus used to disinfect an object before it can come in contactwith a sterile site or to maintain the sterility of an object once ithas entered an enclosure.

FIG. 207 is a pictorial view illustration of an embodiment of a sterilesite apparatus used to disinfect an object before it can come in contactwith a sterile site or to maintain the sterility of an object once ithas entered an enclosure.

FIG. 208 is a pictorial view illustration of an embodiment of a sterilesite apparatus and its associated enclosures, which isolate an objectfrom the user and infectious agents in the ambient surroundings.

FIG. 209 is a pictorial view illustration with hidden lines of thesterile site apparatus and its associated enclosures, which isolate anobject from the user and infectious agents in the ambient surroundings.

FIG. 210 is a pictorial view illustration of an embodiment of a sterilesite apparatus attached to a patient and use during day-to-dayactivities to monitor conditions of the sterile site.

FIG. 211 is a side view illustration of an embodiment of a sterile siteapparatus attached to an intravenous device to disinfect the intravenousdevice or objects that will administer fluids or drugs into theintravenous line.

FIG. 212 is a front view illustration of the sterile site apparatus andintravenous device of FIG. 211.

FIG. 213 is a cross-sectional view illustration of the sterile siteapparatus and intravenous device of FIG. 212 highlighting the internalfeatures of the sterile site apparatus.

FIG. 214 is a pictorial view illustration of an embodiment of a sterilesite apparatus before it is engaged with an intravenous access device.

FIG. 215 is a top view illustration of the sterile site apparatus beforeit is engaged with an intravenous access device.

FIG. 216 is a cross-sectional view illustration of the sterile siteapparatus and intravenous access device of FIG. 215.

FIG. 217 is an enlarged view illustration of the sterile site apparatusof FIG. 216.

FIG. 218 is a pictorial view illustration of the sterile site apparatusafter it is engaged with an intravenous access device.

FIG. 219 is a top view illustration of the sterile site apparatus afterit is engaged with an intravenous access device.

FIG. 220 is a cross-sectional view illustration of the sterile siteapparatus and intravenous access device of FIG. 219.

FIG. 221 is an enlarged view illustration of the sterile site apparatusof FIG. 220 highlighting the use of an EMR barrier to disinfect regionsof the intravenous access device.

FIG. 222 is a front view illustration of an embodiment of a sterile siteapparatus before it couples two tubular medical devices.

FIG. 223 is a top view illustration of the sterile site apparatus afterit couples two tubular medical devices.

FIG. 224 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 223 highlighting its internal features.

FIG. 225 is a pictorial view illustration of an embodiment of a sterilesite apparatus before two pieces of the housing are assembled over atubular medical device.

FIG. 226 is a pictorial view illustration of the sterile site apparatusafter two pieces of the housing are assembled over a tubular medicaldevice.

FIG. 227 is a pictorial view illustration of an embodiment of a sterilesite apparatus before two pieces of the housing are clamped over atubular medical device.

FIG. 228 is a pictorial view illustration of the sterile site apparatusafter two pieces of the housing are clamped over a tubular medicaldevice.

FIG. 229 is a pictorial view illustration of an embodiment of a sterilesite apparatus before the housing is securely attached to a tubularmedical device.

FIG. 230 is a pictorial view illustration of the sterile site apparatusafter the housing is securely attached to a tubular medical device.

FIG. 231 is a top view illustration of an embodiment of a sterile siteapparatus attached to two tubular medical device lines of the samemulti-line tubular medical device.

FIG. 232 is a front view illustration of the sterile site apparatus ofFIG. 231.

FIG. 233 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 232.

FIG. 234 is an enlarged view illustration of the sterile site apparatusof FIG. 233 highlighting its internal features.

FIG. 235 is a pictorial view illustration of an embodiment of a sterilesite apparatus and tubular medical device within the internal pathway ofa patient.

FIG. 236 is a side view illustration of the internal pathway of apatient.

FIG. 237 is a cross-sectional view illustration of the sterile siteapparatus and tubular medical device within the internal pathway of apatient of FIG. 236.

FIG. 238 is a pictorial view illustration of an embodiment of a sterilesite apparatus and tubular medical device within the internal pathway ofa patient.

FIG. 239 is a side view illustration of the internal pathway of apatient.

FIG. 240 is a cross-sectional view illustration of the sterile siteapparatus and tubular medical device within the internal pathway of apatient of FIG. 239.

FIG. 241 is a pictorial view illustration of an embodiment of a sterilesite apparatus within the internal pathway of a patient.

FIG. 242 is a side view illustration of the internal pathway of apatient.

FIG. 243 is a cross-sectional view illustration of the sterile siteapparatus within the internal pathway of a patient of FIG. 242.

FIG. 244 is a pictorial view illustration of an embodiment of a sterilesite apparatus before it is attached to a tubular medical device.

FIG. 245 is a pictorial view illustration of the sterile site apparatusafter it is attached to a tubular medical device.

FIG. 246 is a front view illustration of the sterile site apparatusattached to a tubular medical device and placed in proximity to thepatient.

FIG. 247 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 246 highlighting its internal feature including itstransmission and emission medium.

FIG. 248 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 246 highlighting its internal features and ability toemit an EMR barrier into a tubular medical device and a contaminatedregion.

FIG. 249 is a front view illustration of an embodiment of a sterile siteapparatus attached to a tubular medical device and placed in proximityto the patient.

FIG. 250 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 249 highlighting its internal features including itsheating element.

FIG. 251 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 249 highlighting its internal features and abilityheat the tubular medical device and proximal regions of the patient.

FIG. 252 is a front view illustration of an embodiment of a sterile siteapparatus attached to a tubular medical device and placed in proximityto the patient.

FIG. 253 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 252 highlighting its internal features including itselectromagnetic field generator.

FIG. 254 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 252 highlighting its internal features and ability tocreate an electromagnetic field, which acts on the tubular medicaldevice and proximal regions of the patient.

FIG. 255 is a top view illustration of an embodiment of a sterile siteapparatus positioned over the sterile site.

FIG. 256 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 252 highlighting its features including as retractingfeature, heating elements, and coatings.

FIG. 257 is a pictorial view illustration of an embodiment of a sterilesite apparatus, its unbroken detecting region of the object sensor, andan object.

FIG. 258 is a pictorial view illustration of the sterile site apparatusof FIG. 257 after an object has disrupted the detecting region.

FIG. 259 is a pictorial view illustration of the sterile site apparatus,its unbroken detecting region of the object sensor, and an object.

FIG. 260 is a pictorial view illustration of the sterile site apparatusof FIG. 259 after an object has disrupted the detecting region.

FIG. 261 is a top view illustration of an embodiment of a sterile siteapparatus highlighting its various features.

FIG. 262 is a cross-sectional view illustration of the sterile siteapparatus of FIG. 196 highlighting its various features.

FIG. 263 is an enlarged view illustration of the sterile site apparatusof FIG. 262 highlighting its various features.

FIG. 264 is a cross-sectional view illustration of the embodiment of thesterile site apparatus shown in FIG. 77 to illustrate selected featuresof the sterile site apparatus.

DETAILED DESCRIPTION OF THE INVENTION

Many alterations and modifications may be made to embodiments disclosedherein by those having ordinary skill in the art without departing fromthe spirit and scope of the embodiments. Therefore, it must beunderstood that the illustrated embodiment has been set forth only forthe purposes of example and that it should not be taken as limiting theembodiments as defined by the following embodiments and its variousembodiments.

FIG. 1 illustrates a diagram for the various features and equipment usedby the sterile site apparatus 1. A portion of the sterile site apparatus1 will surround or partially surround the sterile site 52 and/or nearbyregions. For the purposes of this invention, the sterile site 52 is anypoint, line, curve, area, surface, or volume where it is desirable tominimize the number, quantity, or amount of infectious agents. Examplesof sterile sites 52 are a sterile field commonly used during a surgicalor catheterization procedure where the surgical instruments or cathetersare placed for use by the physician, or a surgical site which could be awound, or surgical incision, or place where catheters, ports, orlaparoscopic devices are inserted or implanted, or a laceration,epidermal trauma, pressure sore, or ulcer either external or internal tothe body, or a portion of the body, bed, or room where the transfer ofinfectious agents could result in internal infection of the body, or thespace within a hood or glove bag, the contents of a medicine bottle, ora catheter inner or outer surface such as a urinary catheter, or acatheter hub such as a central venous line, or port for chemotherapy, ora luer fitting, or a tubing line used for IV administration, or anendotracheal tube or tracheostomy tube or fitting. The intention of thesterile site apparatus 1 is to reduce or prevent infections or diseasefrom originating at the sterile site 52. This entails reducing orpreventing infectious agents from coming into contact with the sterilesite 52, or rendering any infectious agents that enter the sterile site52 ineffective at causing infection or disease.

For the purposes of this invention, infectious agent or infectiousagents will mean any particle, particulate, or any single, multicell, oracellular organism or micro-organism, living or dead, including but notlimited to bacteria, fungi, arcaea, spores, protozoa, protists, algae,plants, animals, plankton, planarian, helminthes, and infectiousbiological agents such as viruses, virions, viroids, plasmids, prions,or other autonomous or semi-autonomously replicating genome that isalone, or in combination with other infectious agents, airborne, in agas, in or on a fluid, attached to an object such as a hand, forearm,body part, body article, surgical glove, instrument, catheter, fitting,or any other article that is able to cause infection or disease to aliving body such as an animal or human.

FIG. 1 shows where the inputs and outputs of the various systems andfeatures of the sterile site apparatus 1 can be directed. However, itshould be noted that the sterile site apparatus 1 can include otherfeatures and systems than those shown in FIG. 1. While the sterile siteapparatus 1 may use a variety of configurations, the configurationdisplayed in FIG. 1 shows the control system 20 receiving inputs fromthe sensors 3 and the external database 21. The control system 20 alsosends information to the external database 21 before the control system20 sends signals to other features and systems of the sterile siteapparatus 1 including but not limited to gases 4, solid barrier 23,heating element 2, vibration 5, Electro Magnetic Radiation (EMR) 6, ColdAtmospheric Plasma (CAP) 7, fluids 8, charged particle displacementmechanism 9, and gas handling unit 10. The outputs from the features andsystems of the sterile site apparatus 1 including but not limited togases 4, solid barrier 23, heating element 2, vibration 5, ElectroMagnetic Radiation (EMR) 6, Cold Atmospheric Plasma (CAP) 7, fluids 8,charged particle displacement mechanism 9, and gas handling unit 10 willbe used for functions and applications involving the sterile site 52.The outputs from the gas handling unit 10 can also be used for functionsand applications involving the ambient surroundings 24. For the purposesof this invention, ambient surroundings 24 will mean any point, line,curve, area, surface or volume that is not included part of the sterilesite 52 that may or may not contain infectious agents. The sensors 3will gather information on the sterile site 52, sterile site apparatus1, infectious agents or objects near or in contact with the sterile site52, regions near the sterile site 52 or sterile site apparatus 1, theambient surroundings 24, and the current outputs of the features andsystems of the sterile site apparatus 1. Information from the sensors 3will then be sent to the control system 20. Greater detail on thefunctions and advantages of the features and systems of the sterile siteapparatus 1 can be found below.

The heating element 2 will be used to heat air near the sterile siteapparatus 1 or provide heating or a reduction of heat to or around thesterile site 52. Heated air will create an upward draft that is drivenby density and/or pressure differences in the air. This upward draft ofair is advantageous because it will carry falling infectious agents awayfrom the sterile site 52. When the heating element 2 is used to heat orcool the sterile site apparatus 1 and associated objects, devices, ortissue around the sterile site 52, it minimizes infectious agents ortheir reproduction by creating a barrier of elevated or reducedtemperature. The heating element 2 can create heat by any known meansincluding but not limited to a resistance heater, radiofrequencyheating, chemical heating by combustion or an exothermic reaction, andbe transferred to the sterile site by means of conduction, convection,or radiance. It is also conceived that heating element can create areduction in heat by any known means including but not limited to athermoelectric device (Peltier effect), a heat sink, or an endothermicreaction and can be transferred to the sterile site by means ofconduction, convection, or radiance. Gases 4 can be used by the sterilesite apparatus 1 to serve a variety of functions including but notlimited to disinfecting infectious agents, creating a barrier thatinfectious agents cannot pass through, or displacing infectious agentsaway from the sterile site 52. For example, ozone gas, which hasapplications as a disinfectant, can be pumped near the sterile site 52to aid in the disinfection of infectious agents. Other gases that arebacteriostatic such as CO2 or nitrous oxide can serve to minimizebacteria formation as well as the potential for air embolism.Bactericidal gases such as hypochlorous acid gas, hydrogen peroxide gas,and ozone can be quickly and efficiently neutralized with EMR so thatthey do not escape into the ambient surroundings 24. Wavelengths andfrequencies of Electro Magnetic Radiation, EMR 6, will be used for avariety of purposes. One of the desired wavelength and frequency ranges,such as Ultraviolet (UV-C) light around 200-280 nm can be used todisinfect infectious agents near the sterile site 52. Another wavelengthand frequency range, such as vacuum UV around 185 nm can be used togenerate ozone gas near the sterile site 52. Other types of EMR 6 otherthan vacuum or UVC light can also be used such as UVB, UVA, blue light,microwave, broad spectrum pulsed light (BSPL), pulsed electrical field(PEF), alternating current electric field, direct current electricfield, a high frequency electric field, x-ray, or infrared light asdetermined suitable for reducing infectious agents near the sterile site52. Cold Atmospheric Plasma (CAP) 7 will also be used to create ozonegas and other conditions that will aid in disinfecting infectiousagents. Fluids 8 can also be used to enhance the infection preventingeffectiveness of the sterile site apparatus 1. The Fluids 8 includegases and gas mixtures, gas and liquid mixtures, liquids and liquidmixtures, gas and solid mixtures, and liquid and solid mixtures. Fluids8 can be used by the sterile site apparatus 1 to serve a variety offunctions including but not limited to disinfecting infectious agents,creating a barrier that infectious agents cannot pass through, ordisplacing infectious agents away from the sterile site 52. For example,fluids 8 can include humidified gas, ozonated water vapor, ozonatedwater, CAP activated water vapor, CAP activated water, surfacedisinfectants, antiseptics, antibiotics, antifungal agents, antiviralagents, preservatives, bacteriostatic agents, and bactericides. Acharged particle displacement mechanism 9 will operate by chargingincoming infectious agents either positively or negatively. A componentthat has the same or opposite charge of the infectious agents will theneither attract the infectious agents to a receptor, or repel theinfectious agents away from the sterile site 52. A gas handling unit 10will be used to provide purified or sterile gas to the sterile siteapparatus 1. Multiple purified or sterile gases can be released by thegas handling unit 10, however purified or sterile air is preferable dueto its availability. A solid barrier 23 made of solid materials will beused to create a barrier to partially or completely cover the sterilesite 52 in order to protect the sterile site 52 from the infectiousagents. The solid barrier 23 will be designed so that it will cover thesterile site 52 in a manner that will not inhibit the user fromperforming a desired task. For example, it is conceivable that the solidbarrier 23 will only be created when a medical device or a user's handis not in contact with the sterile site 52. Vibration 5 will be used tofor a variety of functions including but not limited to nebulizingdisinfecting fluids, preventing development of biofilm on a surface, andpreventing infectious agents from resting on the sterile site 52.

The various features and systems of the sterile site apparatus 1 will beactivated or deactivated by the control system 20. The control system 20will have the capability to incorporate sensors 3 and other systemswhich can detect when objects are near the sterile site 52, when thereare changes in conditions at or near the sterile site 52 which warrantsthe systems to turn on or adjust such as when a physician or staffmember is in the room where a medical procedure is being conducted so asto the levels/concentrations of EMR, fluid mixtures and gas mixturesbeing released by the sterile site apparatus 1. Detecting objectsimmediately near the sterile site 52 is beneficial because it may not bedesirable to have certain features of the sterile site apparatus 1, suchas emitting EMR, constantly activated. Controlling the activation of thefeatures will be beneficial by prolonging the service life of thesterile site apparatus 1 and limiting the exposure of EMR to the patientand physician(s). Detecting physicians or staff members in the roomwhere a medical procedure is going to be performed is beneficial becauseit can allow certain features, such as the gas handling unit 10, to beactivated before a medical procedure is performed. This would allow theambient surroundings 24 to be cleaned before a medical procedure isperformed. Additional sensors, systems, and controls such as footswitches, voice, and remote activated control and any others besidesthose mentioned, can also be incorporated into the control system 20.The sensor 3 may be one or many and be the same or different from eachother, it may be located close to the sterile site 52, be within thesterile site equipment 27, or be remotely located. The sensor 3 may beable to measure objects so as to determine size, shape, color, density,and other material and physical attributes. It is conceivable that thesensor 3 will be able to measure other properties of objects such astheir position, position relative to another object so as to determineif objects are touching, velocity, chemistry, and temperature so as tobe able to provide intelligent information to the control system 20,which will serve to activate or deactivate various features of thesterile site apparatus 1. Furthermore, the sensor 3 may be able toprovide information about the condition of the sterile site apparatus 1itself and its related outputs, such as pressures, concentrations,voltage, energy level, flow, temperature, orientation, and geometry.This ability to provide the control system 20 with feedback from sensors3 is advantageous because it will provide input necessary to ensure thatthe sterile site apparatus 1 is performing as expected. The controlsystem 20 will be technologically advanced so as to be able to makedecisions from the inputs of the sensor 3 and combined with informationprovided from the external database 21 such as the internet, a database,or a live operator, be able to appropriately adjust the outputs of thesterile site apparatus 1. For example, ozone gas can be pumped near thesterile site 52 to aid in the disinfection of infectious agents for acontrolled amount of time determined by the control system 20 when anobject is sensed by the sensor 3. As another example, the sensor 3 maydetect a rise in temperature at the sterile site 52, and initiate atimed beam of UV light to the site while outputting a warning signal toa cellular phone or other user interface that would alert the user of anew possible infectious condition.

FIG. 2 illustrates a flow chart describing the gas handling unit 10features and systems used to process intake gas to yield sterile gasand/or purified gas. The intake gas will be drawn from the sterile site52, ambient surroundings 24, and/or the additional gas source 28. Theadditional gas source 28 can provide a variety of gases including butnot limited to CO₂, ozone gas, and inert gases. Sterile gas will bedefined as gas being free of at least 99.99% of all infectious agentsgreater than 0.01 microns. Filtering out objects larger than 0.01microns is desired because some of the smallest known infectious agents,such as the pelagibacter ubique and parvovirus, have their smallestdimensions (0.012 and 0.018 microns, respectively) greater than 0.01microns. Purified gas will be defined as gas being free of at least99.97% of all infectious agents greater than 0.3 microns. Sterile gaswill be used for applications involving the sterile site 52 or theambient surroundings 24. These applications will be discussed in furtherdetail in other embodiment descriptions. Purified gas will be circulatedback into the ambient surroundings 24 to enhance overall sanitation. Thegas handling unit 10 will consist of a dryer 25, pre-filters 11, acharcoal odor removal system 12, a HEPA/ULPA/SULPA filter 13, an EMRdisinfection system 14, an ionizer/ion balancer 15, a gas heater/cooler16, a scrubber/neutralizer 22 and a gas blower 19 for creating purifiedgas. The gas handling unit 10 will consist of a dryer 25, pre-filters11, a charcoal odor removal system 12, a HEPA/ULPA/SULPA filter 13, anEMR disinfection system 14, an ionizer/ion balancer 15, a gasheater/cooler 16, a scrubber/neutralizer 22, a compressor 17, and athree-stage sterile gas filtration system 18 for creating sterile gas.

The dryer 25 will remove moisture and humidity from the incoming gases.The pre-filters 11 will remove large infectious agents from the incominggases. The charcoal odor removal system 12 will remove odors from thegases. The HEPA/ULPA/SULPA filter 13 will remove fine infectious agentsfrom the incoming gases. A HEPA filter will be defined as being capableof removing 99.97% of all infectious agents greater than 0.3 microns. AnULPA filter will be defined as being capable of removing 99.999% of allinfectious agents of the most penetrating particle size at a specifiedgas velocity. A SULPA filter will be defined as being capable ofremoving 99.9999% of all infectious agents of the most penetratingparticle size at a specified gas velocity. The most penetrating particlesize is defined as the approximate particle diameter when penetrationthrough the filter is highest. The EMR disinfection system 14 will usespecific wavelength(s) of EMR (typically UVC radiation in the range of200-280 nm) to disinfect infectious agents in the gases. The ionizer/ionbalancer 15 will create a desired ion balance in the gases to promotehealth benefits for the patient and physician(s) and to assist with thecharged particle displacement mechanism. The gas heater/cooler 16 willheat or cool the gas to a temperature that is comfortable for thepatient and physician(s). The scrubber/neutralizer 22 will reduce theconcentration of potentially harmful gases and substances in theincoming gas. After passing through the dryer 25, pre-filters 11,charcoal odor removal system 12, HEPA/ULPA/SULPA filter 13, EMRdisinfection system 14, ionizer/ion balancer 15, gas heater/cooler 16,and scrubber/neutralizer 22, sterile gas will be created by running gasthrough a compressor 17 followed by forcing the gas through athree-stage sterile gas filtration system 18. In the three-stage sterilegas filtration system 18, gas will be pushed through openings thatdecrease in size from one stage to the next. The size of the openings inthe final stage will be sufficiently small to prevent infectious agentsfrom passing through, which will yield sterile gas. After passingthrough the dryer 25, pre-filters 11, charcoal odor removal system 12,HEPA/ULPA/SULPA filter 13, EMR disinfection system 14, ionizer/ionbalancer 15, gas heater/cooler 16, and scrubber/neutralizer 22, purifiedgas will be yielded by running gas through a blower 19 to propel the gasback into the ambient surroundings. The gas handling unit 10 will havethe ability to create sterile gas and purified gas simultaneously orindependently. It would also be advantageous for the gas handling unit10 to incorporate sensors and systems to monitor the sterile siteapparatus's 1 outputs, including but not limited to gas pressure,temperature and composition, and conditions, including but not limitedto filter obstruction and scrubber effectiveness. This informationgathered by sensors and systems can conceivably be used to notify theuser or other individual of a need for maintenance or repair, such asreplacing a filter or diagnosing the cause of a gas leak, by activatingalarms or other features. It should be noted that additional componentsand systems, which are not shown in FIG. 2, can be incorporated into thegas handling unit 10. The components and systems of the gas handlingunit 10 can be arranged in multiple combinations, arrangements, andorders and can be omitted in order to produce the most optimumconfiguration for a particular need.

One embodiment of the gas handling unit 10 utilizes a combination of CO₂from the additional gas source 28, which is heated by the gasheater/cooler 16 to a temperature in the range of 105 degrees F. to 125degrees F. and administered to the sterile site 52. This increasedtemperature heats the sterile site 52 above the normal body temperaturewhich greatly reduces the growth of bacteria, and simultaneouslystimulates increased blood flow thereby enhancing the body's owndefenses for fighting bacteria. CO2 gas offers the advantage of beingbacteriostatic and reducing the potential for air embolism if venous orarterial vessels have been accessed in the sterile site 52.

FIG. 3 illustrates a sterile site apparatus 1 to reduce the amount ofinfectious agents entering a sterile site 52. It should again be notedthat although figures and discussions contained in this disclosure mayshow or specify a specific type of sterile site 52, such as a sterilefield or surgical site, the sterile site apparatus 1, can be used forapplications involving all types of sterile sites 52. In FIG. 3, thesterile site equipment 27 is connected to the housing 41 via the supplycord 40. The housing 41 can be a rigid, flexible, malleable,collapsible, or inflatable structure and can be composed of a singlepiece or multiple pieces. The housing 41 may also have any of a numberof cross-sectional profiles. The housing 41 may or may not be fullyenclosed, may or may not surround the sterile site 52, and may be madeof one or a combination of multiple materials such as plastic,elastomer, rubber, fabric, fiber, glass, ceramic, metal or composite.The role of the housing 41 is to provide a structure to aid the sterilesite apparatus 1 in performing its various functions. The housing 41 maybe configured to surround or partially surround the sterile site 52, andmay be attached to a surrounding area by means of adhesives, magnets,suction, grip pads, mechanical devices, or other known methods. Thehousing 41 may be configured to be located a distance away from thesterile site 52 to be more applicable for reducing infectious agents onobjects that may later enter the sterile site 52. From the housing 41,the sterile gases, fluid mixtures, EMR, CAP and other features of thesterile site apparatus 1 will be utilized to displace the infectiousagents away from the sterile site 52 or render the infectious agentsunable to cause infection or disease. It should be noted that thesterile site apparatus 1 is surrounded by the ambient surroundings 24,which can contain infectious agents.

If infectious agents come into contact with objects in or entering thesterile site 52, it will be beneficial to disinfect the objects so thatthe infectious agents are unable to cause infection or disease. Thisdisinfection may be accomplished by administering ozone gas, CAP,fluids, or the desired wavelength(s) of EMR. The role of the supply cord40 is to provide the housing 41 or other part(s) of sterile siteapparatus 1 with the necessary materials, gases, liquids, solids,mixtures, electrical power, EMR, CAP, and/or inputs and outputs neededto perform its variety of functions. It should be noted that althoughthe supply cord 40 is shown in FIG. 3 to be connected to the sterilesite equipment 27 and housing 41, the supply cord 40 can be connected toa variety of other components, sources, or systems in addition to, incombination with, or in place of the sterile site equipment 27, or notbe required at all if the sources, systems, controls, and components areincorporated in, on, or attached to the housing 41. For the purposes ofthis invention disclosure, the remaining figures will not show thesterile site equipment 27 connected to the supply cord 40.

FIGS. 4-7 illustrate the gas handling unit's 10 (FIG. 2) ability toremove infectious agent containing air 43 away from the sterile site 52.The sterile site apparatus 1 consists of a supply cord 40 and housing 41ar. The vacuum head 42 is shown in FIGS. 4-7 to depict that it can bearranged in any number of orientations and placements with respect tothe sterile site apparatus 1 and sterile site 52. Infectious agentcontaining air 43 will be pulled into the vacuum head 42 and sent to thegas handling unit via a connecting hose (not shown). It is alsocontemplated that compressed air from the gas handling unit 10 can beused to generate a vacuum effect by blowing into the vacuum head 42 andpulling the infectious agent containing air 43 with it. The advantage ofblowing compressed air to create the negative pressure at the sterilesite 52 is that the connecting hose (not shown) would have less of atendency to collapse due to having a higher pressure than thesurrounding ambient air. The gas handling unit and vacuum head 42 willbe designed and positioned so that no infectious agents will be able tocome into contact with the sterile site 52. The vacuum head 42 may beconnected to the supply cord 40, housing 41 ar, or be supported byanother structure to allow the proper positioning in proximity to thesterile site 52. The vacuum head 42 can work alone or work incombination with other embodiments of the sterile site apparatus 1 aswill be disclosed in this specification. It should also be noted thatthe vacuum head 42 can also be used to exhaust gases 4 (FIG. 1), CAP 7(FIG. 1) gases, sterile or purified gas from the gas handling unit 10(FIG. 1), and fluids 8 (FIG. 1) that may be present at or near thesterile site 52.

FIGS. 8-13 illustrate the gas handling unit's 10 (FIG. 2) ability to usea collapsible vacuum head 50, 50 a, and 50 b to remove infectious agentcontaining air 43 away from the sterile site 52 and its surroundingareas. The collapsible vacuum head 50, 50 a, and 50 b will be designedto be stored and shipped as a collapsed unit it will be used.Immediately before use, the collapsed unit can be folded to yield thecollapsible vacuum head 50, 50 a, and 50 b seen in FIGS. 8-13. Theinfectious agent containing air 43 will flow through the inlet opening54, 54 a, and 54 b to the main enclosure 51, 51 a and 51 b and throughthe outlet opening 53, 53 a, and 53 b, which will connect thecollapsible vacuum head 50, 50 a, and 50 b to the gas handling unit viaa connecting hose (not shown). The portion surrounding the inlet opening54, 54 a, and 54 b will have foldable ends that will create a flaredfeature 56, 56 a, and 56 b to improve air flow. The flared feature 56,56 a and 56 b can have any of a number of appearances and designs asseen in FIGS. 8-13. The collapsible vacuum head 50, 50 a and 50 b can beattached to or near the sterile site 52 by using suction applied throughsmall openings 55 sealed by a gasket 57 seen in FIGS. 8-9, by using grippads 58-59 as seen in FIGS. 10-11, or by using a positively chargedmagnetic pad 60 and a negatively charged magnetic pad 61 as seen inFIGS. 12-13. The gas handling unit and collapsible vacuum head 50, 50 a,and 50 b will be designed so that no infectious agents will be able tocome into contact with the sterile site 52.

FIGS. 14-15 illustrate the ability for the deflated vacuum tube 110 tobe filled with pressurized gas in the region where the two layers oftubing are not attached 112. Pressurized gas will be introduced betweenthe two layers of tubing from the unsealed end 114 to inflate thetubing. The sealed end 113 will prevent pressurized gas from escapingfrom the opposite end of the tube. The resulting inflated vacuum tube115 will maintain its shape from regions where the two layers of tubingare attached 111. Ambient air containing infectious agents near thesealed end 113 will flow through the center of the inflated vacuum tube115 to the unsealed end 114 where the air will then be taken to the gashandling unit 10 (FIG. 2). Although not seen in FIGS. 14-15, theunsealed end 114 will be attached to a structure that will allowpressurized gas to flow into the region between the two layers of tubingwithout allowing pressurized gas to flow out of the region between thetwo layers of tubing.

FIGS. 16-18 illustrate a method for attaching the inflated vacuum tubewith semi-rigid insertion card 126 to the gas handling unit 10 (FIG. 2).The device will consist of an inflated vacuum tube 115 connected to asemi-rigid insertion card 126. Pressurized gas will be introducedbetween the two layers of tubing from the unsealed end 114 (FIG. 15) toinflate the tubing. The sealed end 113 will prevent pressurized gas fromescaping from the opposite end of the tube. The resulting inflatedvacuum tube 115 will maintain its shape from regions where the twolayers of tubing are attached 111. Ambient air containing infectiousagents near the sealed end 113 will flow through the center of theinflated vacuum tube 115 to the unsealed end 114 where the air will thenbe taken to the gas handling unit 10. The outer layer 127 of theinflated vacuum tube 115 will be sealed to the left side of thesemi-rigid insertion card 126 as seen in FIG. 17. The inner layer 128 ofthe inflated vacuum tube 115 will be sealed to the right side of thesemi-rigid insertion card 126 as seen in FIG. 17. There will also be apressurized gas hole 129 that will cross through the inner layer 128 ofthe inflated vacuum tube 115 and/or the semi-rigid insertion card 126.This hole will access the region where the two layers of tubing are notattached 112 to allow inflation of the inflated vacuum tube 115. Forattaching the inflated vacuum tube with semi-rigid insertion card 126 tothe gas handling unit, the semi-rigid insertion card 126 will be slidinto or otherwise attached to a mating feature on the gas handling unitto allow for inflation via the pressurized gas hole 129, as shown inFIG. 18, and also allow the intake of infectious agent containing airthrough the center of the inflated vacuum tube 115.

FIGS. 19-20 illustrate the ability of the sterile site apparatus 1,which consists of a supply cord 40 connected to the housing 41 as, toblow sterile gas 32 and/or ionized gas 73 to prevent infectious agentsfrom coming into contact with the sterile site 52. The sterile gas 32and/or ionized gas 73 will be propelled through gas release openings 31.The gas release openings 31 can consist of orifices, slits, vents and/orother shapes/arrangements and may release any of a number of gasmixtures including, but not limited to purified gas, sterile gas 32,ionized gas 73, ozone gas, humidified gas, carbon dioxide and CAP. Whileembodiments and figures of this document may specify the use of aspecific gas, fluid, solid and/or CAP mixture, it should be noted thatany combination of gases, fluids, solids and/or CAP may be used in itsplace. The released sterile gas 32 and/or ionized gas 73 will displaceinfectious agent containing air 43 away from the sterile site 52. Theuse of ionized gas 73 is desirable because it can cause infectiousagents to be charged either positively or negatively. As will bediscussed in other embodiments, charging the infectious agents can allowthe sterile site apparatus 1 to repel or attract the infectious agentsin a way to prevent contact with the sterile site 52. Additionally, if acluster of infectious agents becomes charged in a way that theindividual infectious agents all have the same charge, the cluster willtend to disintegrate as the individual infectious agents repel eachother. This disintegration is advantageous because the small individualinfectious agents will travel slowly through the air. When theinfectious agents travel slowly, there will be a longer duration of timeavailable for the sterile site apparatus 1 to disinfect or displace theinfectious agents.

FIGS. 21-23 illustrate the ability of the sterile site apparatus 1 toblow sterile gas 32 in various directions and orientations to preventinfectious agent containing air 43 from coming into contact with thesterile site 52. By blowing gas in a non-uniform manner, it allows for awider range of possible designs for the sterile site apparatus 1 and itsgas release openings 31 a. This will allow for better patient care bymore effectively preventing infectious agents from coming into contactwith the sterile site 52. It will also improve the comfort andperformance of physician(s) by preventing gas from being blown in theirdirection, where it could cause discomfort and distraction. The shapeand arrangement of the gas release openings 31 a will be designed toprevent infectious agents from coming into contact with the sterile site52. One preferred embodiment consists of gas release openings 31 a,uniformly surrounding the perimeter of the housing 41 a so that thesterile site 52 is completely surrounding by the flow of gas. The gasrelease openings 31 a can have an opening diameter of 0.001″ to 0.06″,but preferably on the order of 0.010″ with spacing between the gasrelease openings 31 ranging from 0.06″ to 1″ but preferably on the orderof 0.25″ to 0.5″. The pressure of the sterile gas 32 can be in the rangeof 1 psi to 50 psi but is preferably on the order of 10 to 20 psi. Thedesign of the sterile site apparatus 1 will take advantage of flowpatterns and fluid phenomena that result from release and/or intake offluids from/to the sterile site apparatus 1.

FIGS. 24-25 illustrate the ability of the sterile site apparatus 1 toprevent infectious agent containing air 43 from traveling underneath thehousing 41 b and coming into contact with the sterile site 52. Thesterile site apparatus 1 consists of a supply cord 40 and housing 41 b.Sterile gas 32 will be released from gas release openings 31 b in thehousing 41 b. When the sterile gas 32 is released, it will causeinfectious agent containing air 43 to be propelled away from the sterilesite 52. If this feature was not present and the sterile site apparatus1 were to simply rest on top of a surface, it would be possible forinfectious agents to come into contact with the sterile site 52 aftertraveling through gaps between the housing 41 b and the sterile site 52.

FIGS. 26-29 illustrate the ability of the sterile site apparatus 1 tocreate a coherent disinfecting fluid barrier 80, which is created by thefluid release openings 26 contained in the housing 41 c. For thepurposes of this disclosure, the term “coherent” will be used todescribe the disinfecting fluid barrier 80 where the streamlines of thedisinfecting fluids will be approximately convergent, parallel, and/orminimally divergent in at least one plane for desired duration ordistance. The fluid release openings 26 can be oriented and arranged inways to release their contents in any of a number of directions. Thefluid release openings 26 can consist of nozzles, atomizers, nebulizers,jets, orifices, holes, slits and/or other shapes/arrangements and mayrelease any of a number of fluids 8 (FIG. 1) in the form of a liquid,gas, mist, vapor, fog, colloid, solution, or suspension. In addition tothe fluid release openings, heat, impellers, ultrasonic vibration,wicks, or other known technology can be used to combine the fluids 8. Asseen in FIGS. 26 and 28, the liquid lumen 81, gas lumen 82, andsuspended solids lumen 83 will distribute their respective substancesthroughout the housing 41 c. As seen in FIG. 29, the substances willtravel towards the liquid outlet 46, gas outlet 45, and suspended solidsoutlet 44 via the liquid channel 84, gas channel 85, and suspendedsolids channel 86, respectively. For the configuration shown in FIG. 28,the fluid release openings 26 will consist of the various outlets 44,45, and 46. The released liquid 87, released gas 88, and releasedsuspended solids 89 exiting their respective outlets can be mixed eitherexternal to the housing 41 c as seen in FIG. 28 or within the housing 41c. The gas release openings 26 will be designed so that the releasedliquid 87, released gas 88, and released suspended solids 89 will form acoherent disinfecting fluid barrier 80 after being mixed. It should benoted that the sterile site apparatus 1 can consist of a number of othersubstances, lumens, channels, and features than those shown in FIGS.26-29.

FIGS. 30-35 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 at to create and maintain the integrity of anextended fluid barrier 90. The extended fluid barrier 90 will extendoutwards from the sterile site apparatus 1 and will create a distinctboundary between the ambient surroundings containing infectious agentsand the region near the sterile site 52. While the extended fluidbarrier 90 in FIGS. 32-35 is shown as a dome or arcuate shape, theextended fluid barrier 90 may form any of a number of shapes. Theextended fluid barrier 90 will be composed of liquids, gases, and solidsthat will allow the extended fluid barrier 90 to maintain its shapewhile having objects 91 pass through as seen in FIGS. 34 and 35. Uponcoming in contact with an object 91, the liquids, gases, and solidscomposing the extended fluid barrier 90 serve a variety of functionsincluding but not limited to disinfection. Therefore, the extended fluidbarrier 90 will disinfect any objects 91 and infectious agents thatcould come into contact with the sterile site 52. It should be notedthat once the sterile site apparatus 1 creates the extended fluidbarrier 90, it will be desirable to replenish the extended fluid barrier90 with the desired liquids, gases, and solids if any of these materialsare lost or depleted while the extended fluid barrier 90 is in use. Itshould also be noted that the extended fluid barrier 90 will have theability to form or reform itself even when an object 91 or infectiousagent is currently near or in contact with the sterile site 52. Oneembodiment of the extended fluid barrier 90 is formed as a bubble usinga water based soap solution and a substance such as glycerin to increasethe viscosity. A more robust bubble substance can be created by usingpolymeric soaps, block copolymers that have one hydrophobic segmentattached to a hydrophilic segment as they have far better mechanicalproperties and are more able to heal when disrupted. Examples of theseare block copolymers of either polylactic acid or polycaprolactone withpolyethylene glycol. Different combinations of block molecular weightsand ratios of block sizes can provide unique properties of the extendedfluid barrier. Another polymer that has similar properties are blockcopolymers of polyethyleneglycol with polypropylene glycol. The additionof bactericidal fluids such as hypochlorous acid or hydrogen peroxide tothe fluid barrier will disinfect objects that come in contact or passthrough the barrier.

FIGS. 36-41 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 au to create and maintain the integrity of aplanar fluid barrier 90 a. The planar fluid barrier 90 a will extendoutwards from the sterile site apparatus 1 and will create a distinctboundary between the ambient surroundings containing infectious agentsand the region near the sterile site 52. While the planar fluid barrier90 a in FIGS. 38-41 is shown as a planar shape, the planar fluid barrier90 a may form any of a number of shapes. The planar fluid barrier 90 awill be composed of liquids, gases, and solids that will allow theplanar fluid barrier 90 a to maintain its shape while having objects 91pass through as seen in FIGS. 40 and 41. Upon coming in contact with anobject 91, the liquids, gases, and solids composing the planar fluidbarrier 90 a will serve a variety of functions including but not limitedto disinfection. Therefore, the planar fluid barrier 90 a will disinfectany objects 91 and infectious agents that could come into contact withthe sterile site 52. It should be noted that once the sterile siteapparatus 1 creates the planar fluid barrier 90 a, it will be desirableto replenish the planar fluid barrier 90 a with the desired liquids,gases, and solids if any of these materials are lost or depleted whilethe planar fluid barrier 90 a is in use. It should also be noted thatthe planar fluid barrier 90 a will have the ability to form or reformitself even when an object 91 or infectious agent is currently near orin contact with the sterile site 52.

FIGS. 42-47 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 av to use an extended solid barrier 23 a toprevent infectious agents from coming into contact with the sterile site52. The extended solid barrier 23 a would be used when the sterile site52 is not being accessed by the user such as when a medical instrumentis no longer in contact with the sterile site 52, or it may beconfigured so that the leading edges 94 seal around an instrument incontact with the sterile site 52. Sensors 3 (FIG. 1) and control system20 (FIG. 1) may be used to control the extension and retraction of solidbarrier 23 a based on a desired logic sequence. The extended solidbarrier 23 a will also be able to withdraw itself when the user wishesto access the sterile site 52. The solid barrier will be advantageousbecause it will prevent infectious agents contained in the ambientsurroundings from coming into contact with the sterile site 52. FIGS.44-47 also show one of the many possible ways to form the extended solidbarrier 23 a which involves rotating leading edges 94 to pull theextended solid barrier 23 a.

FIGS. 48-53 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 aw to use a planar solid barrier 23 b toprevent infectious agents from coming into contact with the sterile site52. The planar solid barrier 23 b would be used when the sterile site 52is not being accessed by the user such as when a medical instrument isno longer in contact with the sterile site 52, or it may be configuredso that the leading edges of segments 95 seal around an instrument incontact with the sterile site 52. Sensors 3 (FIG. 1) and control system20 (FIG. 1) may be used to control the extension and retraction of solidbarrier 23 b based on a desired logic sequence. The planar solid barrier23 b will also be able to withdraw itself when the user wishes to accessthe sterile site 52. The solid barrier will be advantageous because itwill prevent infectious agents contained in the ambient surroundingsfrom coming into contact with the sterile site 52. FIGS. 50-53 also showone of the many possible ways to form the planar solid barrier 23 bwhich involves drawing multiple segments 95 towards each other untilthey fully seal the sterile site 52 from the ambient surroundings.

FIGS. 54-59 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 ax to use a thin-film solid barrier 23 c toprevent infectious agents from coming into contact with the sterile site52. The thin-film solid barrier 23 c would be used when the sterile site52 is not being accessed by the user such as when a medical instrumentis no longer in contact with the sterile site 52. Sensors 3 (FIG. 1) andcontrol system 20 (FIG. 1) may be used to control the extension andretraction of solid barrier 23 c based on a desired logic sequence. Thethin-film solid barrier 23 c will also be able to withdraw itself whenthe user wishes to access the sterile site 52. The solid barrier will beadvantageous because it will prevent infectious agents contained in theambient surroundings from coming into contact with the sterile site 52.FIGS. 56-59 also show one of the many possible ways to form thethin-film solid barrier 23 c which involves using a rotating dispenser98 to distribute the solid thin-film as the dispenser rotates about afix location.

FIGS. 60-64 illustrate the ability of the sterile site apparatus 1 touse an attachable solid barrier 23 d to prevent infectious agents fromcoming into contact with the sterile site 52. As seen in FIGS. 60-61,the attachable solid barrier 23 d can originally be separate from thehousing 41 ay and then be attached to the housing 41 ay using a varietyof known technologies including but not limited to adhesives, magnets,clamps, and snap fittings. As seen in FIG. 62, once the attachable solidbarrier 23 d is secured to the housing 41 ay, objects 91 such as medicalinstruments will still be able to access the sterile site 52 by passingthrough the attachable solid barrier 23 d. The portion of the attachablesolid barrier 23 d that objects 91 can pass through can use a variety ofknown technologies including but not limited to a slit or permeablemembrane to allow passage of an object 91 while preventing infectiousagents in the ambient surroundings from coming into contact with thesterile site 52. As seen in FIGS. 63-64, the attachable solid barrier 23d will have the ability to be removed from the housing 41 ay withoutdisturbing the positioning of an object 91 that is currently near or incontact with the sterile site 52. FIGS. 63-64 show a possible method forremoving the attachable solid barrier 23 d, which entails separating theattachable solid barrier 23 d along a perforation 99 and lifting theattachable solid barrier 23 d off of the housing 41 ay. It should benoted that the attachable solid barrier 23 d will still preventinfectious agents from coming into contact with the sterile site 52 ifan object 91 is passed into and then out of the attachable solid barrier23 d.

FIGS. 65-69 illustrate the ability of the sterile site apparatus 1 touse an attachable thin-film solid barrier 23 e to prevent infectiousagents from coming into contact with the sterile site 52. As seen inFIGS. 65-68, the attachable thin-film solid barrier 23 e can originallybe separate from the housing 41 az and then by attached to the housing41 az using a variety of known technologies including but not limited toadhesives, magnets, clamps, and electrostatic mechanisms. Similar to theattachable solid barrier 23 d (FIGS. 60-64), the attachable thin-filmsolid barrier 23 e can have an object 91 inserted through the solidbarrier while still preventing the infectious agents from coming intocontact with the sterile site 52. The attachable thin-film solid barrier23 e can be made from variety of known materials including but notlimited to a flexible polymer, tyvek (DuPont), and rubber. It should benoted that the attachable thin-film solid barrier 23 e will stillprevent infectious agents from coming into contact with the sterile site52 if an object 91 is passed into and then out of the attachablethin-film solid barrier 23 e.

FIGS. 70-72 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 ba to change its shape in order to reduce thesize of the sterile site 52 and thereby reduce the possibility ofinfectious agents contained in the ambient surroundings from coming intocontact with the sterile site 52. FIGS. 70-72 show the sterile siteapparatus 1 and its associated housing 41 ba changing its shape tosuccessively reduce to the size of the sterile site 52 and create a sealaround an object 91 that is in contact with the sterile site 52. Theopening/closing feature 130 can act to change the shape of the sterilesite apparatus 1 and its associated housing 41 ba and to maintain thatshape. The housing 41 ba can be constructed with valorous features suchas hinges, or linkages, or be a flexible material that may either beelastic or malleable depending on if the housing is to stay in aposition or elastically open or close. The housing can also beconfigured to be soft so that it can seal around object 91, or be thinso as to allow the body tissue to seal around the object 91. Theopening/closing feature 130 can use a variety of known technologiesincluding but not limited to pneumatics, electric actuators, forcesapplied by the user, snap features magnets, adhesives, and clamps tochange and maintain the shape of the sterile site apparatus 1. It isconceivable that the sterile site apparatus 1 can maintain an openshape, as seen in FIG. 70, when the user needs clear access to thesterile site 52 and then change to and maintain a closed shape, as seenin FIG. 72, when the user does not need clear access to the sterile site52. It should be noted that it is also conceivable for the sterile siteapparatus 1 to maintain a closed shape, as seen in FIG. 72, and thenchange to and maintain an open shape, as seen in FIG. 70. Sealing thesterile site apparatus 1 around an object 91 is advantageous because itwill prevent infectious agents from coming into contact with the sterilesite while also maintaining the positioning of the object 91 while theuser is not accessing the sterile site 52.

FIG. 73 illustrates the ability of the sterile site apparatus 1 to emitthe EMR barrier 161. The EMR barrier 161 will be composed of the desiredwavelength(s) of EMR that disinfect infectious agents before they enterthe sterile site 52. The EMR barrier 161 may have diverging beams of EMRbut preferably are composed of convergent, parallel, and/or minimallydivergent beams of the desired wavelength(s) of EMR. For the purposes ofthis disclosure, the term “coherent” will be used to describe the EMRbarrier 161 where the EMR beams will be convergent, parallel, and/orminimally divergent in at least one plane. The EMR barrier 161 will becoherent in order to protect physicians from exposure to undesiredlevels of EMR that are emitted by the sterile site apparatus 1. For FIG.73, the role of the desired wavelength(s) of EMR will be to disinfectinfectious agents, medical instruments and other objects coming intocontact with the sterile site 52. The housing 41 bb will distribute thedesired wavelength(s) of EMR to the EMR emitters 160 or the EMR emitters160 can generate the desired wavelength(s) of EMR. EMR emitters 160 canbe composed of any number of point or line sources. The EMR emitters 160will emit the coherent EMR barrier 161 to provide a complete coverage ofthe area above the sterile site 52 that is encompassed by the sterilesite apparatus 1. The term “barrier” is used to describe a clear, free,unimpeded, shadow-free region, surface, plane, area, or volume with theability to pass multiple non-touching objects simultaneously through andstill maintain complete contact with each object along its perimeter. Asan object passes through the coherent EMR barrier 161, the object willbe disinfected by the desired wavelength(s) of EMR. By disinfecting anyobject that could come into contact with the sterile site 52, the riskfor infection will be reduced.

FIGS. 74-76 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 bc to disinfect the entire exterior surface ofan object 173 passing through the sterile site apparatus 1 even whenmultiple additional objects 174 and 175 are present. While many EMRemitters can be used at the same time, only single EMR emitters 160 a,160 b, and 160 c will be shown in FIGS. 74-76 in order to highlight theadvantages of the sterile site apparatus 1. For FIGS. 74-76, the role ofthe desired wavelength(s) of EMR emitted by the EMR emitters 160 a, 160b, and 160 c will be disinfection. EMR paths 176, 176 a, and 176 b ofthe desired wavelength(s), which sum to form the coherent EMR barrier,can also be seen in FIGS. 74-76. The objects 173-175 represent objectssuch as infectious agents, medical devices, or a physician's hands beingpassed through the coherent EMR barrier and towards the sterile site 52.To highlight the advantages of the sterile site apparatus 1, object 173will be focused on to show how the sterile site apparatus 1 is able todisinfect the exterior surface of the object 173 when multipleadditional objects 174-175 are also present. As seen in FIG. 74, the EMRemitter 160 a is able to expose the lower left portion of the object 173to the desired wavelength(s) of EMR. As seen in FIG. 75, the EMR emitter160 b is able to expose the upper right portion of the object 173 to thedesired wavelength(s) of EMR. As seen in FIG. 76, the EMR emitter 160 cis able to expose the lower right portion of the object 173 to thedesired wavelength(s) of EMR. Therefore, the combinations of the EMRemitters 160 a, 160 b, and 160 c are able to completely disinfect theexterior surface of the object 173. This feature is advantageous becausemultiple objects are frequently introduced near a sterile site 52 duringthe course of a medical procedure. It should also be noted that the EMRemitters 160 a, 160 b, and 160 c, can be replaced in FIGS. 74-76 withgas release openings 31 (FIG. 20) or fluid release openings 26 (FIG. 26)that have the same ability to completely disinfect the exterior surfaceof the objects 173-175 using disinfecting gases and gas mixtures, gasliquid mixtures, liquids and liquid mixtures, gas and solid mixtures,and/or liquid and solid mixtures as opposed to EMR.

FIG. 77 illustrates the ability of the sterile site apparatus 1 tocreate a coherent EMR barrier 161 a out of convergent beams 184 of thedesired wavelength(s) of EMR using a highly convex lens 183 and desiredwavelength(s) of EMR 182 emitted from point source EMR emitters 160 dcontained within the housing 41 d. The reflective surface 181 isadvantageous because it will allow more EMR energy to actively contactobjects passing through the coherent EMR barrier 161 a. It should benoted that the highly convex lens 183 can be used in conjunction with orreplaced by additional lenses and optics to produce to the coherent EMRbarrier 161 a composed of convergent beams 184 of the desiredwavelength(s) of EMR. It is contemplated that the materials for theoptics will be compatible with the EMR. For example, a lens can beselected from conventional lenses that are compatible with suitablelevels of EMR.

FIG. 78 illustrates the ability of the sterile site apparatus 1 tocreate a coherent EMR barrier 161 b out of parallel beams 186 of thedesired wavelength(s) of EMR using a slightly convex lens 185 anddesired wavelength(s) of EMR 182 emitted from point source EMR emitters160 d contained within the housing 41 d. The reflective surface 181 isadvantageous because it will allow more EMR energy to actively contactobjects passing through the coherent EMR barrier 161 b. It should benoted that the slightly convex lens 185 can be used in conjunction withor replaced by additional lenses and optics to produce to the coherentEMR barrier 161 b composed of parallel beams 186 of the desiredwavelength(s) of EMR.

FIG. 79 illustrates the ability of the sterile site apparatus 1 tocreate a coherent EMR barrier 161 a out of convergent beams 184 of thedesired wavelength(s) of EMR using a highly convex lens 183 and desiredwavelength(s) of EMR 182 emitted from a line source EMR emitter 160 econtained within the housing 41 e. The reflective surface 181 isadvantageous because it will allow more EMR energy to actively contactobjects passing through the coherent EMR barrier 161 a. It should benoted that the highly convex lens 183 can be used in conjunction with orreplaced by additional lenses and optics to produce to the coherent EMRbarrier 161 a composed of convergent beams 184 of the desiredwavelength(s) of EMR.

FIG. 80 illustrates the ability of the sterile site apparatus 1 tocreate a coherent EMR barrier 161 b out of parallel beams 186 of thedesired wavelength(s) of EMR using a slightly convex lens 185 anddesired wavelength(s) of EMR 182 emitted from a line source EMR emitter160 e contained within the housing 41 e. The reflective surface 181 isadvantageous because it will allow more EMR energy to actively contactobjects passing through the coherent EMR barrier 161 b. It should benoted that the slightly convex lens 185 can be used in conjunction withor replaced by additional lenses and optics to produce to the coherentEMR barrier 161 b composed of parallel beams 186 of the desiredwavelength(s) of EMR.

FIG. 81 further illustrates the advantage of the sterile site apparatus1 using a reflective surface 181 a. The inner reflective surface 181 aof the housing 41 f will have characteristics to allow it to reflectcertain wavelength(s) of EMR emitted from the EMR emitter 160 f. Areflective surface 181 a will allow the desired wavelength(s) of EMR totraverse a greater distance before dissipating. This can be seen in FIG.81, where a beam of the desired wavelength(s) of EMR would follow theEMR path 176 c. The reflective surface 181 a is advantageous because itwill allow more EMR energy to actively disinfect objects passing throughthe coherent EMR barrier. This will allow the sterile site apparatus 1to operate with greater energy efficiency by reducing the rate of EMRdissipation in the coherent EMR barrier.

FIGS. 82-84 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 bd to have the desired wavelength(s) of EMRpulsed from multiple EMR emitters 160 g, 160 h, and 160 i at differenttime intervals. FIGS. 82-84 show the progression of EMR emitters beingactivated at successive time intervals. It also shows representations ofthe EMR paths 176 d, 176 e, and 176 f taken by the desired wavelength(s)of EMR. Initially, the EMR emitters 160 g emit EMR, which follows theEMR paths 176 d. This is followed by the EMR emitters 160 h emittingEMR, which travels the EMR paths 176 e. Finally, the EMR emitters 160 iemit EMR, which follows the EMR paths 176 f. The intensity andwavelength(s) of the EMR composing the pulses will provide sufficientpower to disinfect any infectious agent or object that could come intocontact with the sterile site 52. Using pulsed EMR is advantageous overusing constantly emitted EMR because the pulsed EMR will be more energyefficient and prolong the service life of the sterile site apparatus 1.

FIGS. 85-87 illustrate the ability of the sterile site apparatus 1 touse the EMR emitter 160 j to emit the divergent beams 231 of EMR invarious directions at successive time intervals, which results in asweeping motion. While minimally divergent beams 231 of EMR are shown,other types of beams can be used including but not limited to convergentbeams and parallel beams. A single of multiple EMR emitters 160 j may beused. The sterile site apparatus 1 and its EMR emitter 160 j will beable to direct the minimally divergent beams 231 in a way to providedisinfection for a portion of the region where an infectious agent orobject can come into contact with the sterile site 52. Allowing a beamof the desired wavelength(s) of EMR to be directed in various directionsis advantageous because it will provide any given EMR emitter 160 j theability to disinfect a larger portion of the region where an infectiousagent or object can come into contact with the sterile site 52. Theminimally divergent beams 231 can sweep the area encompassed by thehousing 41 g by rotating, oscillating, or vibrating the source, a lensor reflective surface, any other known technologies or technologiesdetermined in the future.

FIG. 88 illustrates the function of the EMR filtration unit 240, whichwill be used with the sterile site apparatus. The EMR filter 241 willfunction by filtering the incoming broad spectrum EMR 242 to yield thefiltered EMR 243. The filtered EMR 243 can then be used for a variety ofpurposes. Because the EMR filter 241 can only reduce the intensity ofthe wavelengths contained in the broad spectrum EMR 242, the intensityof the wavelengths contained in the broad spectrum EMR 242 must begreater than or equal to the intensity of the desired wavelengths of thefiltered EMR 243.

FIG. 89 illustrates the function of the EMR reflection unit 250, whichwill be used with the sterile site apparatus. The EMR reflector 251 willfunction by reflecting the incoming broad spectrum EMR 242 to yield thereflected EMR 244. The reflected EMR 244 can then be used for a varietyof purposes. Because the EMR reflector 251 can only reduce the intensityof wavelengths contained in the broad spectrum EMR 242, the intensity ofthe wavelengths contained in the broad spectrum EMR 242 must be greaterthan or equal to the intensity of the desired wavelengths of thereflected EMR 244. It should be noted that the EMR reflection unit 250can be used by the reflective surface (FIGS. 77-81).

FIG. 90 illustrates the function of the EMR emission unit 253, whichwill be used with the sterile site apparatus 1 (FIG. 1). The emissionmaterial 254 will function by emitting the desired wavelength(s) of EMR255 after the emission material 254 is acted upon by an input 252. Thedesired wavelength(s) of EMR 255 can have a variety of applications,which are further discussed throughout this document and include but arenot limited to disinfection, illumination, and ozone gas generation. Thenature of the input 252 can include but is not limited to mechanical,magnetic, electrostatic, electrical, EMR, thermal, and chemical stimuli.It should be noted that the emission material 254 can consist ofmultiple combined materials or a single material. If multiple materialsare used, the ways they can be combined include but is not limited tocoating, doping and mixing.

Another example of how the EMR emission unit 253 can operate is as ascintillator whereby the emission material 254 is a scintillatingmaterial that luminesces when excited by input 252 which could be in theform of ionizing radiation emitted by a fluoroscope. This is beneficialin alerting the user of ionizing radiation in or near the sterile site52 (FIG. 1) which could be harmful to the user, specifically the user'shands which are typically unprotected from direct exposure to theradiation beam. FIG. 91 illustrates the function of the EMRamplification unit 257, which will be used with the sterile siteapparatus 1 (FIG. 1). The EMR amplifier 258 will function by emittingthe amplified EMR 259 after the EMR amplifier 258 is acted upon by theincoming EMR 256. It should be noted that the wavelength of the incomingEMR 256 and the wavelength of the amplified EMR 259 will be the same.However, the energy of the amplified EMR 259 will be greater than theenergy of the incoming EMR 256.

FIG. 92 illustrates the use of a coating 260 on the surface of an object261. The coating 260 can serve a variety of functions including but notlimited to antibacterial purposes, antimicrobial purposes, antifungalpurposes, antiviral purposes, producing thermal energy, conductingthermal energy, producing EMR, and adhesion. The coating 260 can be usedon any number of surfaces on any part or feature of the sterile siteapparatus. Coatings and fillers can be used with the sterile siteapparatus and its housing to impart various features that improve thesterile site apparatus' function. Antimicrobial or antibacterialcoatings and fillers will prevent the adherence, growth, and propagationof infection agents on the housing and other components of the sterilesite apparatus. Antibiotics, antivirals, antifungals, and antiparasiticsare commonly used. Organic acids such as lactic acid, citric acid, andacetic acid, and their salts have been used effectively. Essential oilssuch as bay, cinnamon, clove and thyme have been found to be inhibitiveto bacterial growth. Heavy metal cations such as colloidal silver orcopper alloys have substantial antimicrobial properties and are widelyused on medical devices to prevent biofilm formation. Other hydrophobiccoatings such as silicone oil and hydrophilic coatings can also preventbacterial adherence. Thermally conductive coatings and fillers are usedto transfer heat and cooling throughout a material that has poorerthermal conductance. Ceramic and chemical compound fillers such asalumina, boron nitride, iron-oxide, beryllium oxide, aluminum nitride,aluminum oxide, zinc oxide, silicon dioxide, or metal powders such asaluminum, copper, and silver, or liquid metal alloys such as gallium, orallotropes of carbon such as diamond, graphite, carbon fiber,fullerenes, and graphene can be used in greases, plastics, elastomersand rubbers to improve the thermal conductivity.

FIGS. 93-94 illustrate the ability for the line source toroid convexlens apparatus 262, which is contained in the sterile site apparatus, touse a toroid convex lens 263 and a line source EMR emitter 160 l toproduce a coherent EMR barrier. The cross-sectional profile of the lensas seen in FIG. 94 will determine whether parallel, convergent, orminimally divergent beams of EMR are produced. It should be noted thatthe toroid convex lens 263 can be used in conjunction with a variety ofadditional lenses and optics to produce a coherent EMR barrier.

FIGS. 95-96 illustrate the ability for the point source toroid convexlens apparatus 264, which is contained in the sterile site apparatus, touse a toroid convex lens 263 and point source EMR emitters 160 k toproduce a coherent EMR barrier. The cross-sectional profile of the lensas seen in FIG. 96 will determine whether parallel, convergent, orminimally divergent beams of EMR are produced. It should be noted thatthe toroid convex lens 263 can be used in conjunction with a variety ofadditional lenses and optics to produce a coherent EMR barrier.

FIGS. 97-98 illustrate the ability for the line source toroid meniscuslens apparatus 270, which is contained in the sterile site apparatus, touse a toroid meniscus lens 271 and a line source EMR emitter 160 l toproduce a coherent EMR barrier. The cross-sectional profile of the lensas seen in FIG. 98 will determine whether parallel, convergent, orminimally divergent beams of EMR are produced. It should be noted thatthe toroid meniscus lens 271 can be used in conjunction with a varietyof additional lenses and optics to produce a coherent EMR barrier.

FIGS. 99-100 illustrate the ability for the point source toroid meniscuslens apparatus 272, which is contained in the sterile site apparatus, touse a toroid meniscus lens 271 and point source EMR emitters 160 k toproduce a coherent EMR barrier. The cross-sectional profile of the lensas seen in FIG. 100 will determine whether parallel, convergent, orminimally divergent beams of EMR are produced. It should be noted thatthe toroid meniscus lens 271 can be used in conjunction with a varietyof additional lenses and optics to produce a coherent EMR barrier.

FIGS. 101-102 illustrate the ability for the line source toroidplano-convex lens apparatus 280, which is contained in the sterile siteapparatus, to use a toroid plano-convex lens 281 and a line source EMRemitter 160 l to produce a coherent EMR barrier. The cross-sectionalprofile of the lens as seen in FIG. 102 will determine whether parallel,convergent, or minimally divergent beams of EMR are produced. It shouldbe noted that the toroid plano-convex lens 281 can be used inconjunction with a variety of additional lenses and optics to produce acoherent EMR barrier.

FIGS. 103-104 illustrate the ability for the point source toroidplano-convex lens apparatus 282, which is contained in the sterile siteapparatus, to use a toroid plano-convex lens 281 and point source EMRemitters 160 k to produce a coherent EMR barrier. The cross-sectionalprofile of the lens as seen in FIG. 104 will determine whether parallel,convergent, or minimally divergent beams of EMR are produced. It shouldbe noted that the toroid plano-convex lens 281 can be used inconjunction with a variety of additional lenses and optics to produce acoherent EMR barrier.

FIGS. 105-106 illustrate the ability for the line source multiplepartial-toroid convex lens apparatus 290, which is contained in thesterile site apparatus, to use a multiple partial-toroid convex lens 291and a line source EMR emitter 160 l to produce a coherent EMR barrier.The cross-sectional profile of the lens as seen in FIG. 106 willdetermine whether parallel, convergent, or minimally divergent beams ofEMR are produced. It should be noted that the multiple partial-toroidconvex lens 291 can be used in conjunction with a variety of additionallenses and optics to produce a coherent EMR barrier.

FIGS. 107-108 illustrate the ability for the point source multiplepartial-toroid convex lens apparatus 292, which is contained in thesterile site apparatus, to use a multiple partial-toroid convex lens 291and point source EMR emitters 160 k to produce a coherent EMR barrier.The cross-sectional profile of the lens as seen in FIG. 108 willdetermine whether parallel, convergent, or minimally divergent beams ofEMR are produced. It should be noted that the multiple partial-toroidconvex lens 291 can be used in conjunction with a variety of additionallenses and optics to produce a coherent EMR barrier.

FIGS. 109-110 illustrate the ability for the line source multiplepartial-toroid meniscus lens apparatus 300, which is contained in thesterile site apparatus, to use a multiple partial-toroid meniscus lens301 and a line source EMR emitter 160 l to produce a coherent EMRbarrier. The cross-sectional profile of the lens as seen in FIG. 110will determine whether parallel, convergent, or minimally divergentbeams of EMR are produced. It should be noted that the multiplepartial-toroid meniscus lens 301 can be used in conjunction with avariety of additional lenses and optics to produce a coherent EMRbarrier.

FIGS. 111-112 illustrate the ability for the point source multiplepartial-toroid meniscus lens apparatus 302, which is contained in thesterile site apparatus, to use a multiple partial-toroid meniscus lens301 and point source EMR emitters 160 k to produce a coherent EMRbarrier. The cross-sectional profile of the lens as seen in FIG. 112will determine whether parallel, convergent, or minimally divergentbeams of EMR are produced. It should be noted that the multiplepartial-toroid meniscus lens 301 can be used in conjunction with avariety of additional lenses and optics to produce a coherent EMRbarrier.

FIGS. 113-114 illustrate the ability for the line source multiplepartial-toroid plano-convex lens apparatus 310, which is contained inthe sterile site apparatus, to use a multiple partial-toroidplano-convex lens 311 and a line source EMR emitter 160 l to produce acoherent EMR barrier. The cross-sectional profile of the lens as seen inFIG. 114 will determine whether parallel, convergent, or minimallydivergent beams of EMR are produced. It should be noted that themultiple partial-toroid plano-convex lens 311 can be used in conjunctionwith a variety of additional lenses and optics to produce a coherent EMRbarrier.

FIGS. 115-116 illustrate the ability for the point source multiplepartial-toroid plano-convex lens apparatus 312, which is contained inthe sterile site apparatus, to use a multiple partial-toroidplano-convex lens 311 and point source EMR emitters 160 k to produce acoherent EMR barrier. The cross-sectional profile of the lens as seen inFIG. 116 will determine whether parallel, convergent, or minimallydivergent beams of EMR are produced. It should be noted that themultiple partial-toroid plano-convex lens 311 can be used in conjunctionwith a variety of additional lenses and optics to produce a coherent EMRbarrier.

FIGS. 117-118 illustrate the ability of the sterile site apparatus 1 todeliver fiber optics 320 throughout the housing 41 h via the supply cord40. It should be noted that the fiber optics 320 can still bedistributed throughout the sterile site apparatus 1 if the housing 41 his not present. The fiber optics 320 will carry the desiredwavelength(s) of EMR, which will be generated at a source connected toor separate from the housing 41 h. The fiber optics 320 will be able toefficiently carry the desired wavelength(s) of EMR without a significantdecrease in power.

FIGS. 119-120 illustrate the ability of the sterile site apparatus 1 todeliver a power wire 325 throughout the housing 41 i via the supply cord40. The power wire 325 will power the internal EMR emitters 160 m, whichwill generate the desired wavelength(s) of EMR. The internal EMRemitters 160 m are contained within the housing 41 i.

However, it should be noted that other EMR emitters can be locatedanywhere within, attached to, or distant to the sterile site apparatus1. The desired wavelength(s) of EMR generated by the internal EMRemitters 160 m can be sent to a system of the sterile site apparatus 1,which will create an EMR barrier. The power wire 325 can also be usedfor a variety of additional systems and features.

FIGS. 121-123 illustrate the ability of the sterile site apparatus 1 tohave a transmission channel 335 distribute the desired wavelength(s) ofEMR throughout the housing 41 j. The desired wavelength(s) of EMR willbe delivered to the transmission channel 335 via the supply cord 40 orother means. The transmission channel 335 will be composed of atransmission medium 339, which will efficiently transmit the desiredwavelength(s) of EMR without a significant decrease in power, and areflective surface 181 b, which will reflect the desired wavelength(s)of EMR throughout the transmission medium 339. EMR will travelthroughout the transmission channel 335 as peripheral EMR 337 until itis reflected towards an outlet 340. Peripheral EMR 337 that is reflectedtowards an outlet 340 will be designated as reflected EMR 244. Thereflected EMR 244 will then be used by a system of the sterile siteapparatus 1, which will create the EMR barrier with the desiredwavelength(s) of EMR.

FIGS. 124-127 illustrate the ability of the sterile site apparatus 1 tohave its housing 41 k be in a non-circular and potentially non-planarconfiguration by being flexible and malleable. After the housing 41 k ismolded to a desired shape by the physician(s) or medical staff, thesterile site apparatus 1 will still be able to create an EMR barrier 161c from the EMR emitters 160 n. This malleable feature is advantageousbecause it will allow a custom shape to be created for each patient tomeet his or her individual needs. This will be especially useful forsterile sites 52 that have an unusual, non-uniform shape. It is alsocontemplated for the housing 41 k not being continuous, fully enclosed,or connected all the way around, so that the housing 41 k can stillprovide a barrier for sterile sites 52 that may already be enclosed onone or more sides by a projecting wall or other barrier. While showingseveral features of the housing 41 k, FIG. 127 highlights the malleableportion 350. For this particular embodiment, the housing 41 k will bemade of a non-rigid material while the malleable portion 350 is made ofa material can be molded/bent to the desired shape. The sterile siteapparatus 1, housing 41 k, and malleable portion 350 will be designed sothat the EMR barrier 161 c will not be directed in a manner that willcause an increased exposure of EMR to the patient and/or physician(s).FIG. 127 also shows the fluid and gas lumens 351, which can be used todeliver fluid and/or gas near the sterile site 52, and the fiber optics320, which can deliver the desired wavelength(s) of EMR throughout thehousing 41 k. It should be noted that the sterile site apparatus 1 cancontain additional components, systems, and features than those shown inFIGS. 124-127. It should also be noted that the housing 41 k of thesterile site apparatus 1 can be pre-fabricated in a particular desiredshape that may or may not be malleable, so it can be used as is withouthaving to be formed by the medical staff.

FIGS. 128-129 illustrate the ability of the sterile site apparatus 1 tobe composed of multiple housing links 360, which will form the housing41 l. The housing links 360 and their method of attaching to one anotherwill be designed to ensure that the EMR barrier 161 d, which is createdby the EMR emitters 160 o, will not be directed in a manner that willcause an increased exposure of EMR to the patient and/or physician(s).Similar to the malleable housing, the housing links 360 will allow for acustom shape of the housing 41 l of the sterile site apparatus 1. Thehousing links 360 can be hinged in a single plane so that the housing 41l stays in a plane perpendicular to the hinged members, the housinglinks 360 can be hinged in alternating ninety degree planes so that thehousing 41 l can be angled perpendicularly out of plane, or the housinglinks 360 can be hinged in any plane in any order so that the housing 41l can assume any shape. The housing links 360 can be loose, a frictionfit, or be detented to lock into discrete positions depending on thedesired function of the housing 41 l.

FIGS. 130-131 illustrate the ability of the sterile site apparatus 1 toconsist of a housing 41 be and a single EMR emitter 160 an, which willbe powered by the supply cord 40. Additionally, an object sensor 3 a maybe used in conjunction with the EMR emitter 160 an. For example, theobject sensor 3 a senses an object about to enter the sterile site 52,which causes the control system 20 (FIG. 1) to turn on the EMR emitter160 an so that it can generate the desired wavelength(s) of EMR and sendit to the housing 41 be. The advantage of using an object sensor 3 a forcontrolling the EMR emitter 160 an is that the EMR barrier will only beon when it is needed to disinfect infectious agents before they enterthe sterile site 52, thereby lowering EMR exposure to the sterile site52 and to any persons in proximity to the sterile site 52. Locating theEMR emitter 160 an closer to the sterile site 52 will be beneficialbecause the EMR power will be used efficiently. If fiber optics or othertransmission means were used to bring the desired wavelength(s) of EMRfrom a distant EMR emitter or generator, EMR power would be dissipated.This would be detrimental because the sterile site apparatus 1 wouldneed to draw greater power in order to emit a given level of EMR. Acooling unit 371 can also be used in conjunction with the EMR emitter160 an in order to prevent overheating/wear/damage. Using a cooling unit371 will prolong the service life of the sterile site apparatus 1. Thecooling unit 371 can consist of a small fan, fin arrays, pumped coolantsystem, or other forms of heat sinks. If solid state LED's are used togenerate the EMR, then cooling unit 371 may not be needed.

FIGS. 132-133 illustrate the ability of the sterile site apparatus 1 toconsist of a single EMR emitter 160 an, which will be powered by thesupply cord 40. It should be noted that this design does not utilize ahousing. Additionally, an object sensor 3 a, and a cooling unit 371 maybe used in conjunction with the EMR emitter 160 an in a similar mannerto FIG. 131.

FIGS. 134-135 illustrate the ability of the sterile site apparatus 1 toconsist of a housing 41 m and a multiple EMR emitters 160 ao, which willbe powered by the supply cord 40 and secondary supply cords 40 a.Additionally, object sensors 3 b, cooling units 371 a may be used inconjunction with the EMR emitters 160 ao in a similar manner to FIG.131.

FIGS. 136-137 illustrate the ability of the sterile site apparatus 1 toconsist of a multiple EMR emitters 160 ao, which will be powered by thesupply cord 40 and secondary supply cords 40 a. It should be noted thatthis design does not call for a housing. Additionally, object sensors 3b, and cooling units 371 a may be used in conjunction with the EMRemitters 160 ao in a similar manner to FIG. 131.

FIGS. 138-142 illustrate the ability for the sterile site apparatus 1 toconsist of a positively charged electrode 390, housing 41 bf and supplycord 40. FIGS. 138-142 focus on the function of the positively chargedelectrode 390 in the presence of falling infectious agents 391 andionized gas containing electrons 392. The ionized gas containingelectrons 392 can be created by the ionizer/ion balancer 15 of the gashandling unit 10 (FIG. 2). FIGS. 140-142 are depicting the sterile siteapparatus 1 at successive time intervals. When the falling infectiousagents 391 travel towards the sterile site 52, as seen in FIG. 140, theinfectious agents 391 will pass through ionized gas containing electrons392. When the falling infectious agents 391 come into contact with theelectrons 392, they will become attached to each other, as seen in FIG.141. Because of the opposite charges, the negatively charged objectconsisting of infectious agents 391 and electrons 392 will becomeattracted to the positively charged electrode 390, as seen in FIG. 142.By doing so, the infectious agents 391 will be prevented from cominginto contact with the sterile site 52. Although the FIGS. 138-142 depictthe positively charged electrode 390 as a separate component from thehousing 41 bf, it is also contemplated that the positively chargedelectrode 390 is integrated with or attached to the housing 41 bf.

FIGS. 143-147 illustrate the ability for the sterile site apparatus 1 toconsist of a negatively charged electrode 393, housing 41 bf and supplycord 40. FIGS. 143-147 focus on the function of the negatively chargedelectrode 393 in the presence of falling infectious agents 391 andionized gas containing protons 394. The ionized gas containing protons394 can be created by the ionizer/ion balancer 15 of the gas handlingunit 10 (FIG. 2). FIGS. 145-147 are depicting the sterile site apparatus1 at successive time intervals. When the falling infectious agents 391travel towards the sterile site 52, as seen in FIG. 145, the infectiousagents 391 will pass through ionized gas containing protons 394. Whenthe falling infectious agents 391 come into contact with the protons394, they will become attached to each other, as seen in FIG. 146.Because of the opposite charges, the positively charged objectconsisting of infectious agents 391 and protons 394 will becomeattracted to the negatively charged electrode 393, as seen in FIG. 147.By doing so, the infectious agents 391 will be prevented from cominginto contact with the sterile site 52. Although the FIGS. 143-147 depictthe negatively charged electrode 393 as a separate component from thehousing 41 bf, it is also contemplated that the negatively chargedelectrode 393 is integrated with or attached to the housing 41 bf.

FIGS. 148-152 illustrate the ability for the sterile site apparatus 1 toconsist of a negatively charged electrode 393, housing 41 bf and supplycord 40. FIGS. 148-152 focus on the function of the negatively chargedelectrode 393 in the presence of falling infectious agents 391 andionized gas containing electrons 392. The ionized gas containingelectrons 392 can be created by the ionizer/ion balancer 15 of the gashandling unit 10 (FIG. 2). FIGS. 150-152 are depicting the sterile siteapparatus 1 at successive time intervals. When the falling infectiousagents 391 travel towards the sterile site 52, as seen in FIG. 150, theinfectious agents 391 will pass through ionized gas containing electrons392. When the falling infectious agents 391 come into contact with theelectrons 392, they will become attached to each other, as seen in FIG.151. Because of the similar charges, the negatively charged objectconsisting of infectious agents 391 and electrons 392 will be repelledby the negatively charged electrode 393, as seen in FIG. 152. By doingso, the infectious agents 391 will be prevented from coming into contactwith the sterile site 52. Although the FIGS. 148-152 depict thenegatively charged electrode 393 as a separate component from thehousing 41 bf, it is also contemplated that the negatively chargedelectrode 393 is integrated with or attached to the housing 41 bf.

FIGS. 153-157 illustrate the ability for the sterile site apparatus 1 toconsist of a positively charged electrode 390, housing 41 bf and supplycord 40. FIGS. 153-157 focus on the function of the positively chargedelectrode 390 in the presence of falling infectious agents 391 andionized gas containing protons 394. The ionized gas containing protons394 can be created by the ionizer/ion balancer 15 of the gas handlingunit 10 (FIG. 2). FIGS. 155-157 are depicting the sterile site apparatus1 at successive time intervals. When the falling infectious agents 391travel towards the sterile site 52, as seen in FIG. 155, the infectiousagents 391 will pass through ionized gas containing protons 394. Whenthe falling infectious agents 391 come into contact with the protons394, they will become attached to each other, as seen in FIG. 156.Because of the similar charges, the positively charged object consistingof infectious agents 391 and protons 394 will be repelled by thepositively charged electrode 390, as seen in FIG. 157. By doing so, theinfectious agents 391 will be prevented from coming into contact withthe sterile site 52. Although the FIGS. 153-157 depict the positivelycharged electrode 390 as a separate component from the housing 41 bf, itis also contemplated that the positively charged electrode 390 isintegrated with or attached to the housing 41 bf.

FIGS. 158-159 illustrate the ability for the sterile site apparatus 1 toemit the ozone-generating EMR 411, which will create an ozone-filledregion 412 near the sterile site 52. The ozone-generating EMR 411 willbe released by ozone-generating EMR emitters 160 q. The ozone-generatingEMR 411 will be generated within the housing 41 n or it will bedelivered via the supply cord 40. The ozone-generating EMR 411 will beemitted at the specific wavelength(s) and intensities to generate ozonegas near the sterile site 52, for example UV light at 185 nm iseffective at creating a percentage of ozone from oxygen found in the airor fluids at the sterile site 52. Focus is placed on creating ozone gasor ozonated fluid because it will act to disinfect infectious agents inor near the sterile site 52. The ozone filled region 412 of the sterilesite 52 will not present a risk of exposure to the patient andphysician(s) because of several possible factors—1) the ozone gas couldbe created at minimal concentrations that are not harmful, 2) theozonated fluid would be at a concentration that is not harmful, and 3)the ozone gas can be reverted to oxygen gas if it passes through an EMRbarrier 161 e. The EMR barrier 161 e will be created by the EMR emitters160 p. The desired wavelength(s) of EMR used in the EMR barrier 161 ewill contain the wavelength(s) of EMR necessary to turn the ozone gasinto oxygen gas, for example UV light at 200 nm-280 nm, and morespecifically 254 nm is effective at converting a percentage of ozone gasback to oxygen gas. This occurrence makes the containment of ozone gasto the sterile site 52 possible. The feature of reverting ozone gas tooxygen gas is advantageous because it will reduce or eliminate excessiveexpose of ozone gas to the patient and physician(s). FIGS. 160-161illustrate the ability of the sterile site apparatus 1 to create apositive pressure region 422 in or near the sterile site 52. The sterilegas 32 needed to create this positive pressure region 422 will bereleased from gas release openings 31 c. Sterile gas 32 will bedelivered to the housing 410 via the supply cord 40. The positivepressure region 422 is advantageous because it will cause a flow ofsterile gas 423 to leave the sterile site 52. This flow of sterile gas423 is advantageous because it will propel infectious agents away fromthe sterile site 52.

FIGS. 162-163 illustrate the ability of the sterile site apparatus 1 topump ozone gas 431 into or near the sterile site 52 to create an ozonefilled region 412 a. The ozone gas 431 will be released from gas releaseopenings 31 d. The ozone gas 431 will be delivered to the housing 41 pvia the supply cord 40. Focus is placed on using ozone gas 431 becauseit will act to disinfect infectious agents in or near the sterile site52. The ozone filled region 412 a of the sterile site 52 will notpresent a risk of exposure to the patient and physician(s) as discussedin FIGS. 158-159 because the ozone gas 431 may be reverted to oxygen gasif it passes through an EMR barrier 161 f. This EMR barrier 161 f willbe created by the EMR emitters 160 r. As has been previously discussed,the EMR barrier 161 f will contain the necessary wavelength(s) of EMR toturn ozone gas 431 into oxygen gas. This occurrence makes thecontainment of ozone gas 431 to the sterile site 52 possible.

FIGS. 164-165 illustrate the ability of the sterile site apparatus 1 toprovide fluids 8 a into or near the sterile site 52. The fluids 8 a willbe released from the fluid release openings 26 a in the housing 41 q tobe delivered near the sterile site 52 to form a coherent disinfectingfluid barrier 80 a, a top cloud 445 between the sterile site apparatus 1and the ambient surroundings, and/or a bottom cloud 442 between thesterile site apparatus 1 and the sterile site 52. As the fluids 8 a usedfor disinfection are typically denser than the surrounding air, theywill form a boundary for airborne infectious agents as well asinfectious agents attached to objects such as surgical gloves, devicesor instruments entering the sterile site 52. The fluids 8 a may bedelivered to the housing 41 q via the supply cord 40, be injected, or becontained in a structure attached to the housing 41 q. FIG. 164 shows afluid reservoir 446, which will contain the fluids 8 a used during amedical procedure, and an access port 447, which will be used to deliverthe fluids 8 a to the fluid reservoir 446 or the housing 41 q. FIGS.166-170 illustrate the ability of the sterile site apparatus 1 to emitpulses of ozone-generating EMR 411 and ozone-eliminating EMR 463. Theozone-generating EMR 411 and ozone-eliminating EMR 463 will be emittedfrom the ozone-generating EMR emitters 160 t and ozone-eliminating EMRemitters 160 s, respectively. The ozone-generating EMR 411 and theozone-eliminating EMR 463 can be delivered to the housing 41 r via thesupply cord 40. FIGS. 167-170 show the sterile site apparatus 1 atsuccessive time intervals. As seen in FIG. 167, the initial stepinvolves pulsing the ozone-generating EMR 411 into or near the sterilesite 52. As seen in FIG. 168, the result will be an ozone-filled region412, which will disinfect any infectious agents in or near the sterilesite 52. While the ozone filled region 412 is still present, as seen inFIG. 169, the ozone-eliminating EMR 463 will be pulsed into or near thesterile site 52. As seen in FIG. 170, the result will be a sterile site52 that no longer contains the ozone-filled region 412. The feature ofpulsing ozone-generating EMR 411 and ozone-eliminating EMR 463 isadvantageous because it will reduce or eliminate excessive expose ofozone gas to the patient and physician(s).

FIGS. 171-172 illustrate the ability of the sterile site apparatus 1 touse an object sensor 3 c, which is contained in the housing 41 s, todetect an object 91 passing near or into the sterile site 52. The object91 can be large objects, such as a physician's hand(s), medical device,or small microscopic objects such as infectious agents. FIGS. 171 and172 depict one of the detecting mechanisms that can be used by theobject sensor 3 c, which uses a detecting region 471. When an object 91passes near or through this detecting region 471, a disrupted region 472will result. This disruption can be used as a means toactivate/deactivate various features of the sterile site apparatus 1.For example, when an object 91 disrupts the detecting region 471, itcould cause a feature to disinfect the object 91 before it comes intocontact with the sterile site 52. A variety of contact and non-contactobject sensors 3 c, such as a microswitch, infrared, ultrasonic,capacitance, laser, laser scanner, laser displacement, optical,inductance, photoelectric, light sensor, pressure sensor, temperaturesensor, biosensor or numerous others, can be used. While the objectsensor 3 c described in FIGS. 171-172 shows a distinct detecting region471 and disrupted region 472, these regions do not have to be includedin the object sensor 3 c so long as the functional aspects of the sensorare ensured.

FIGS. 173-174 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 bg to use several sensors to gain informationon the sterile site 52 and objects/infectious agents contained outsideof the sterile site 52 and to detect if an object/infectious agent willto come into contact with the sterile site 52. As also seen in FIGS.171-172, FIG. 174 shows the object sensor 3 c and its associateddetecting region 471 a to detect if an object will come into contactwith the sterile site 52. The object sensors 3 b will be used to gaininformation on the objects contained outside of the sterile site 52. Theobject sensors 3 b will determine an object's shape, external andinternal geometry, material composition, position, velocity, trajectory,type of infectious agent or object, surface characteristics, andsusceptibility to various types of disinfection or displacement alongwith various other characteristics, properties, and features. Thesterile site sensors 3 d will be used to gain information on the sterilesite 52. The sterile site sensors 3 d will determine a sterile site's 52shape, external and internal geometry, material/tissue composition, ifan object or infectious agent is in contact with the sterile site 52,type of object or infectious agent, surface characteristics,temperature, and susceptibility to various types of disinfection alongwith various other characteristics, properties, and features. Allsensors of the sterile site apparatus 1, will be used toactivate/deactivate, modify, and/or alter various features of thesterile site apparatus 1 including but not limited to EMR intensity, EMRwavelength(s), fluid or gas mixture composition, fluid or gasdelivery/removal rate, electrode power, CAP delivery rate, and ioniccomposition of fluids or gases.

In one example, the sensors may be configured to monitor the amount ofEMR that is emitted in the EMR barrier and/or in the vicinity of thesterile site 52. The sensors may also provide the monitored data to thecontrol system 20 which may then provide feedback to the emitters toadjust the amount of EMR in the EMR barrier and/or the sterile site 52accordingly.

FIGS. 175-176 illustrate the function of the visible light detectionsystem 707, which will be used by the sterile site apparatus 1 (FIG. 1).The visible light detection system 707 will be used to detect thepresence of an object 91, which could come into contact with the sterilesite 52. The detection of an object 91 is advantageous because it can beused as an input for the control system 20 (FIG. 1) to activate ordeactivate various features of the sterile site apparatus 1 such ascreating an EMR barrier 161 (FIG. 73.) The visible light detectionsystem 707 will consist of components and features including but notlimited to those seen in FIGS. 175-176. Visible light 700 will enter thetransmission structure 708 via the visible light inlet 705. Thetransmission structure 708 will be designed and composed of materials toallow efficient transmission of visible light and keep the visible lightcontained within the transmission structure 708. One of the featuresthat will aid in this containment is the reflective end surface 706,which will prevent undesired losses of visible light by reflecting thevisible light in the transmission structure 708 back towards and intothe transmission structure 708. The visible light inlet 705 will allowthe visible light 700 to enter the transmission structure 708 and alsominimize the amount of visible light that can escape from thetransmission structure 708. While the visible light inlet 705 in FIGS.175 and 176 is shown as a continuous feature along the top of thetransmission structure 708, the visible light inlet 705 can have any ofnumber of segments, components, orientations and patterns. Once thevisible light 700 enters and is contained within the transmissionstructure 708, it will be released from the visible light outlet 701.

When an object 91 is not present near the sterile site 52, the visiblelight leaving the visible light outlet 701 will be described as highlevels of visible light 702. The intensity and power of the high levelsof visible light 702 will be detected by the visible light sensor 3 f.When an object 91 is located near the sterile site 52, it will create ashadow 703 that will prevent some of the visible light 700 from enteringthe transmission structure 708. By preventing some visible light 700from entering the transmission structure 708, lower levels of visiblelight 710 will leave the visible light outlet 701. The intensity andpower of the lower levels of visible light 710 will be detected by thevisible light sensor 3 f. The control system 20 will be able todetermine when an object 91 is moving towards the sterile site 52because the object 91 will cause a decrease in the visible lightdetected by the visible light sensor 3 f. Also, the control system 20will be able to determine when an object 91 is moving away from thesterile site 52 because the object 91 will cause an increase in thevisible light detected by the visible light sensor 3 f.

FIGS. 177-178 illustrate the function of the visible light detection andEMR emission system 722, which will be used by the sterile siteapparatus 1 (FIG. 1). The visible light detection and EMR emissionsystem 722 will be used for two purposes: detecting an object 704 nearthe sterile site 52 and emitting an EMR barrier 161. To address thefunction of the visible light detection and EMR emission system 722, itwill be helpful to observe its similarities to the visible lightdetection system 707 in FIGS. 175-176, which includes its ability todetect an object 704 near the sterile site 52 by observing changes inthe amount of visible light detected by the visible light sensor 3 g.The visible light inlet/EMR emitter 720 will function similar to thevisible light inlet 705, but the visible light inlet/EMR emitter 720will also be able to emit EMR that can be used to create the EMR barrier161. While the visible light inlet/EMR emitter 720 in FIGS. 177 and 178is shown as a continuous feature along the inner face of thetransmission structure 723, the visible light inlet/EMR emitter 720 canhave any of number of segments, components, orientations and patterns.The reflective end face 721 will function similar to the reflective endface 706, but the reflective end face 721 will also be able to reflectother desired wavelengths of EMR in addition to visible light. Thetransmission structure 723 will function similar to the transmissionstructure 708, but the transmission structure 723 will also be able totransmit and contain other desired wavelengths of EMR in addition tovisible light. The visible light outlet/EMR inlet 727 will functionsimilar to the visible light outlet 701, but the visible lightoutlet/EMR inlet 727 will also be able to receive EMR 726 from the EMRemitter 160 u. The visible light sensor 3 g will function similar to thevisible light sensor 3 f. For the purpose of emitting an EMR barrier161, EMR 726 released by the EMR 160 u will enter the transmissionstructure 723 via the visible light outlet/EMR inlet 727. After beingefficiently transmitted and contained within the transmission structure723, the EMR will be released from the visible light inlet/EMR emitter720. The EMR will then be used to create the EMR barrier 161. As shownin FIG. 176, a shadow 703 from an object 704 will cause a change in theamount of visible light detected by the visible light detection and EMRemission system 722, which can be used as an input to trigger thecreation of an EMR barrier 161 to disinfect the object 704 before it cancome into contact with the sterile site 52.

FIGS. 179-180 illustrate the ability of the sterile site apparatus 1 tobe composed of a multitude of various features and systems. While FIG.180 shows these features and systems collectively, it should be notedthat they can be omitted and additional features or systems can beincluded. The primary power line 486, primary fiber optics for the EMRbarrier 488, primary fiber optics for EMR entering the sterile site 489,fluid and gas lumen 351 a for the gas release openings 31 e, and theliquid lumen 81 a, gas lumen 82 a, and suspended solids lumen 83 a forthe fluid release openings 26 b will be supplied or powered by thesupply cord 40.

The primary power line 486 will branch off to form secondary power lines480, which will power the object sensors 3 b and 3 c, sterile sitesensor 3 d, visible light EMR emitter(s) 160 ar, desired wavelength(s)of EMR emitter(s) 160 ap, sterile site EMR emitter 160 aq, and thepositively charged electrode 390 a. The sensors 3 b, 3 c, and 3 d, asdepicted in FIGS. 171-174, will act as a mechanism toactivate/deactivate and/or adjust various features of the sterile siteapparatus 1 when an object, such as a physician's hand or infectiousagent, has been sensed near or on the sterile site 52 or when conditionsof the sterile site 52 change. The object sensor 3 c will be able to“see” objects through an object sensor opening 497 or it will senseobjects through the housing 41 t if the object sensor opening 497 is notpresent. The visible light EMR emitter(s) 160 ar will generate visiblelight, which will be used to enhance the visibility of the area near thesterile site 52. The desired wavelength(s) of EMR emitters 160 ap willgenerate the desired wavelength(s) of EMR, which will be used to createthe EMR barrier. The sterile site EMR emitters 160 aq will be used togenerate the sterile site EMR that can be emitted into or near thesterile site 52. The function of the sterile site EMR includes but isnot limited to illuminating the sterile site 52, generating ozone gasand eliminating ozone gas. The positively charged electrode 390 a willbe used to attract or repel infectious agents away from the sterile site52. While a positively charged electrode 390 a is shown in FIG. 180, anegatively charged electrode can be used in its place.

The primary fiber optics for the coherent EMR barrier 488 willdistribute the desired wavelength(s) of EMR needed for the EMR barrier.The primary fiber optics for the EMR barrier 488 will branch off to formsecondary fiber optics for the EMR barrier 485. The secondary fiberoptics for the EMR barrier 485 will emit their contents to form linesource EMR emitters 160 w, point source EMR emitters 160 v, or any of anumber of types of forms not shown in FIG. 180. The various types of EMRfrom the visible light EMR emitter(s) 160 ar, the desired wavelength(s)of EMR emitter(s) 162 ap, the line source EMR emitter(s) 160 w, and thepoint source EMR emitter(s) 160 v will be passed through the opticsmechanism 496. The optics mechanism 496 will take various wavelengths ofEMR and focus them into an EMR barrier. While a convex profile is shownfor the optics mechanism 496 in FIG. 180, a configuration of any numberof any types of lenses and optics can be used. To form the EMR barrier,the light will initially pass through the reflective surface 181 c.However, the reflective surface 181 c will only allow EMR to pass in thedirection leading to the area above the sterile site 52. In other words,EMR traveling from the area above the sterile site 52 towards thereflective surface 181 c will be reflected back towards the area abovethe sterile site 52.

The primary fiber optics for EMR entering the sterile site 489 willbranch off to form secondary fiber optics for EMR entering the sterilesite 492, which will emit sterile site EMR into or near the sterile site52. The sterile site EMR from the secondary fiber optics for EMRentering the sterile site 492 and sterile site EMR emitters 160 aq willpass through a sterile site EMR opening 494 to access the sterile site52 and its surroundings.

The sterile site apparatus 1 will also include a fluid and gas lumen 351a, liquid lumen 81 a, gas lumen 82 a, and suspended solids lumen 83 a.The fluid and gas lumen 351 a will supply the gas release openings 31 e.The liquid lumen 81 a, gas lumen 82 a, and suspended solids lumen 83 awill supply the fluid release openings 26 b. These lumens can supplygases, liquids, solids, gas mixtures, liquid mixtures, solids mixtures,gas and liquid mixtures, gas and solid mixtures, liquid and solidmixtures, and liquid, gas, and solid mixtures including but not limitedto ozone gas, sterile gas, sterile humidified gas, carbon dioxide, CAP,antibiotics. These mixtures can be delivered near the sterile site 52through fluid release openings 26 b. The functions of the gas releaseopenings 31 e can include but are not limited to infectious agentdisplacement and disinfection. The function of the fluid releaseopenings 26 b will include but is not limited to disinfection of thesterile site 52.

FIGS. 181-183 illustrate the ability of the sterile site apparatus 1,which consists of an attached suction gasket 511, to be sealed againstthe sterile site 52 using suction. This can be performed by creating aregion of negative pressure 510 within the housing 41 u. The region ofnegative pressure 510 can either be generated by the sterile siteequipment 27 (FIG. 3) or be incorporated into the profile of the suctiongasket 511 similar to a suction cup. Using suction to attach the sterilesite apparatus 1 to the sterile site 52 will ensure that the sterilesite apparatus 1 is secure and will prevent infectious agents fromcoming into contact with the sterile site 52 after they travel under thesterile site apparatus 1.

FIGS. 184-185 illustrate the ability of the sterile site apparatus 1,which consists of an attached conformable gasket 520, to be sealedagainst the sterile site 52. Having a conformable gasket 520 attached tothe bottom of the sterile site apparatus 1 will allow the sterile siteapparatus 1 to be sealed against the patient or drape even when anon-uniform surface 521 is encountered. The conformable gasket 520 mayalso minimize the angulation that the housing 41 bh undergoes to contourto a non-uniform surface 521, thereby allowing the housing 41 bh toremain oriented in a single plane. To prevent infectious agents fromcoming into contact with the sterile site 52, the conformable gasket 520should be designed to completely seal the bottom surface of the sterilesite apparatus 1 to the sterile site 52.

FIGS. 186-189 illustrate the ability of the sterile site apparatus 1,which consists of an attached positively charged magnetic strip 530, tobe sealed against the sterile site 52 using a negatively chargedmagnetic strip 531. Note that although FIGS. 186-189 show the positivelycharged magnetic strip 530 initially attached the sterile site apparatus1 and the negatively charged magnetic strip 531 initially attached tothe sterile site 52, the position of the strips can be reversed. Thesterile site apparatus 1 and sterile site 52 surface will be attachedand sealed to each other once the positively charged magnetic strip 530and negatively charged magnetic strip 531 engage. To prevent infectiousagents from coming into contact with the sterile site 52, the magneticstrips 530 and 531 should be designed to completely seal the bottomsurface of the sterile site apparatus 1 and housing 41 bi (if present)to the sterile site 52. FIGS. 190-191 illustrate the ability for thesterile site apparatus 1 to protect the sterile site 52 and the userfrom being exposed to EMR released at a potentially harmful trajectory541, which is released by the EMR emitter(s) 160 x. The EMR released ata potentially harmful trajectory 541 will be prevented from reaching thepatient and physician(s) by using a shield 540, which is attached to andsurrounds the sterile site apparatus 1. The shield 540 will be composedof features/materials that will not allow the transmission, reflection,or refraction of high levels of potentially harmful EMR to thesurrounding areas where the patient and physician(s) will be located.The shield 540 is shown positioned on both sides of the housing 41 v,but may be partial or complete and on one or both sides of the housing41 v as required to reduce potentially harmful trajectories 541. It isalso noted that the shield 540 can be utilized to reduce harmfultrajectories of gases 4 (FIG. 1), CAP 7 (FIG. 1), fluids 8 (FIG. 1), andsterile or purified gas from the gas handling unit 10 (FIG. 1) in placeof or in addition to the EMR. The shield 540 will help to guarantee thatoperating the sterile site apparatus 1 poses minimal to no danger to thepatient and user.

FIGS. 192-193 illustrate the ability of the sterile site apparatus 1 touse a retracting feature 542 to maintain, decrease, and/or increase thesize of the opening that is used to access the sterile site 52 whilealso preventing infectious agents contained on the exterior surface 544from coming into contact with the sterile site 52. It should be notedthat for the embodiment shown in FIGS. 192-193, the sterile site 52 islocated within a mass of body tissue 547. While the sterile siteapparatus 1 shown in FIGS. 192-193 illustrates the retracting feature542 attached to the housing 41 bj, the retracting feature 542 can belocated anywhere with respect to the sterile site apparatus 1 and may beused with or without the housing 41 bj. It is conceivable that theexterior surface 544 can be the skin of a patient. It is conceivablethat the isolated region 546 is exposed body tissue 547. The interfaceregion 545 is part of the exterior surface 544 that is coincident withthe isolated region 546. The retracting feature 542 can retract bodytissue 547 by interacting with existing retraction equipment, by beingopened, closed, and shaped by the user, or by being automaticallyopened, closed, and shaped by the sterile site apparatus 1 and itsassociated control system 20 (FIG. 1). The retracting feature 542 can bemade of a variety of known materials including but not limited to thosethat are flexible, rigid, and malleable. It should be noted that theretracting feature 542 can be made of a single or multiple componentsand have appearances, shapes, and configurations other than that shownin FIGS. 192-193. Without the use of the retracting feature 542,infectious agents on the exterior surface 544 could migrate to thesterile site 52 after the infectious agents at the interface region 545and exterior surface 544 are contacted by objects, such as a user's handor medical instrument. When these objects are in contact with thesterile site 52, the infectious agents will then also come into contactwith the sterile site 52. The retracting feature 542 will create theisolated region 546 and cover the interface region 545. By covering andisolating the interface region 545, infectious agents at the interfaceregion 545 will not come into contact with object such as the user'shand or a medical device.

FIGS. 194-195 illustrate the ability of the sterile site apparatus 1 toinclude an ergonomic attachment 550, which will improve the comfort andhealth of the users using the sterile site apparatus 1. It should benoted that the ergonomic attachment 550 can consist of a single ormultiple pieces and can be located anywhere on the sterile siteapparatus 1. The shape of the single or multiple pieces of the ergonomicattachment 550 can be different than that shown in FIGS. 194-195, andmay or may not be adhered to the housing 41 bk.

FIGS. 196-198 illustrate the ability of the sterile site apparatus 1 tobe composed of a multitude of various features and systems. While FIGS.197 and 198 show these features and systems collectively, it should benoted that some features can be omitted and additional features orsystems can be included. The positively charged electrode 390 b, whichis part of the charged particle displacement mechanism 9 (FIG. 1), willact to attract or repel infectious agents in a manner to prevent themfrom coming into contact with the sterile site 52. It should be notedthat although FIG. 198 shows a positively charged electrode 390 b beingused, a negatively charged electrode can be used in its place. The gasrelease opening 31 f will release sterile gas 32 or other gas mixturesto displace infectious agents in a way that will prevent them fromcoming into contact with the sterile site 52. The shield 540 a willprotect the patient and physician(s) from being exposed to EMR releasedat a potentially harmful trajectory. While the EMR barrier 161 g, whichis created by the EMR emitters 160 y, will be designed to prevent EMRfrom being released at a potentially harmful trajectory, the safetyfeature of using the shield 540 a will help to guarantee that operatingthe sterile site apparatus 1 poses minimal to no danger to user. Anergonomic attachment 550 a can be used to improve the comfort and healthof the user operating the sterile site apparatus 1. An attachmentmechanism 573 will be used to attach and/or seal the sterile siteapparatus 1 to the sterile site 52. The attachment mechanism 573 canconsist of multiple or single magnetic strips, gaskets, grip pads,adhesives, or suction features. The attachment mechanism 573 isconfigured so the sterile site apparatus 1 will be firmly attached tothe sterile site 52 while creating a seal to prevent infectious agentsfrom passing under the housing 41 w, which could cause the infectiousagents to come into contact with the sterile site 52. A detecting region471 b, which is created by the object sensor 3 c, can be used to detecta physician's hand, small objects, such as a hemostat, and microscopicobjects, such as infectious agents, traveling into or near the sterilesite 52. The object sensor 3 b will be used to detect objects in theambient surroundings near the sterile site apparatus 1. The sterile sitesensor 3 d will monitor conditions of the sterile site 52 including butnot limited to infectious agents in contact with the sterile site 52 andgrowth of an infection. The ability to detect the presence of an objectnear the sterile site 52 or the conditions of the sterile site 52 willallow certain features of the sterile site apparatus 1, such asilluminating the sterile site 52 or creating an EMR barrier 161 g, to beactivated only when needed. This will prolong the service life of thesterile site apparatus 1 and minimize exposure to unnecessary radiationand potentially harmful chemicals. The EMR barrier 161 g can be used todisinfect objects that can come into contact with the sterile site 52 byusing the desired wavelength(s) of EMR. The EMR barrier 161 g can have avariety of functions including but not limited to disinfection andillumination. A coherent EMR barrier will be able to disinfect theentire exterior surface of an object before it comes into contact withthe sterile site 52. It will also be able to disinfect the exterior ofobjects traveling towards the sterile site 52 even when multiple objectsare simultaneously passing through the sterile site apparatus 1. It isimplied that the EMR barrier 161 g is planar, following a plane definedby the inner diameter of the housing 41 w, however, it is alsocontemplated that the EMR barrier 161 g be arcuate or shaped like adome, whereby the electromagnetic radiation follows the contour of agas, fluid or solid shape. Sterile site EMR 577, which is released byseparate EMR emitters 160 z, will be released in the area in or near thesterile site 52, where it can perform a number of functions includingbut not limited to ozone generation, ozone elimination, andillumination. Fluids 8 b will be released in the area in or near thesterile site 52 by fluid release openings 26 c to perform a variety offunctions that include but are not limited to mold spore neutralizationand infectious agent disinfection. A vacuum head 42 a can also be usedto remove infectious agent containing air 43 away from the sterile site52. It should also be noted that the portions of the sterile siteapparatus 1 of FIG. 197 that are on or near the sterile site 52 must beconfigured to be sterile so as not to transmit infectious agents to thesterile site 52. This may be accomplished by any combination of a) theportions of the sterile site apparatus 1 that are on or near the sterilesite 52 are sterilized and re-usable (able to be cleaned andre-sterilized by common sterilization methods such as autoclaving,ethylene oxide gas, gamma, or ebeam); b) the portions of the sterilesite apparatus 1 that are on or near the sterile site 52 are sterilizedand disposable; c) the portions of the sterile site apparatus 1 that areon or near the sterile site 52 are covered with a sterile cover; or d)the portions of the sterile site apparatus 1 that are on or near thesterile site 52 are able to be self-sterilized by the sterile siteapparatus 1 itself before or during its use.

FIGS. 199-202 illustrate to ability of the housing 41 x and supply cord40 of the sterile site apparatus 1 to be covered by a sterile sleeve600. FIGS. 199-202 show the progression as the sterile sleeve 600 isslid on the housing 41 x followed by the supply cord 40. The sterilesleeve 600 is advantageous because it will ensure that any portion ofthe sterile site apparatus 1 that is used on or near a sterile site 52will not cause contamination of the sterile site 52. The sterile sleeve600 can be made of any material, but preferably it is made of plastic,and more specifically out of polyethylene which is commonly used as adisposable sterile covering for medical equipment and apparatus. It isalso contemplated to create a porous sterile sleeve 600 that will allowgas and fluid mixtures to pass through, such as Tyvek (DuPont) which iscommonly used for sterile medical apparatus. It is further contemplatedthat the sterile sleeve 600 be made of a combination of materials suchas polyethylene and Tyvek that would not hinder the performance of thesterile site apparatus 1 as described in the preceding embodiments.

FIGS. 203-204 illustrate the ability of the housing 41 b 1 of thesterile site apparatus 1 to be covered by a sterile, rigid cover, whichconsists of a sterile, rigid top component 610 and a sterile, rigidbottom component 611. The sterile, rigid top component 610 and bottomcomponent 611, will attach to form a sterile rigid cover for the housing41 b 1. The sterile, rigid cover is advantageous because it will ensurethat any portion of the sterile site apparatus 1 that is used on or neara sterile site will not cause contamination of the sterile site. Thesterile, rigid cover can be made of any material, but preferably it ismade of plastic or glass, and more specifically out of acrylic,polycarbonate, or quartz which is commonly used in medical equipment andapparatus, especially when it is desirable to be transparent. It is alsocontemplated that the sterile, rigid cover be made of a combination ofmaterials such as acrylic and tyvek that would not hinder theperformance of the sterile site apparatus 1 as described in thepreceding embodiments.

FIG. 205 illustrates the use of a movable arm 620 with sterile siteapparatus 1 to allow the user to place the sterile site apparatus 1 in alocation near the sterile site. The movable arm 620 can consist ofmovable joints 144, hollow rigid members 143, and attachment location621. The movable arm 620 can use joints that can maintain their positionby friction, locking, or any other method commonly used with articulatedarms to position and hold medical apparatus.

FIG. 206 illustrates how an object 634 can be disinfected or kept freeof infectious agents by using a sterile site apparatus 1. An object 634can be disinfected or kept free of infectious agents by passing itthrough an EMR barrier 161 h, which is created by the EMR emitter 160aa, and into an enclosure created by the housing 41 y. This sterile siteapparatus 1 is advantageous because it gives users the ability todisinfect their hands, forearms, gloves, medical instruments, or otherobjects before they come into contact with a sterile site 52. Thehousing 41 y can be supported by a pole 632 and base 633, or it can bemounted on a wall or any other structure that can support the housing 41y and provide ample access to the user. It is also contemplated that anyof the features described in the preceding embodiments can besubstituted for or combined with the EMR barrier 161 h to enhance thesterile site apparatus 1 of FIG. 206. For example, ozone gas flowinginto the housing 41 y will disinfect the enclosure and preventinfectious agents from existing in the sterile site 52.

FIG. 207 illustrates how an object in an enclosure can be kept free ofinfectious agents by using a sterile site apparatus 1. An object 634 acan be kept free of infectious agents by passing it through an EMRbarrier 161 i, which is created by the EMR emitter 160 ab, and into anenclosure created by the housing 41 z. It is also contemplated that anyof the features described in the preceding embodiments can besubstituted for or combined with the EMR barrier 161 i to enhance thesterile site apparatus 1 of FIG. 207. For example, sterile gas flowinginto the housing 41 z will create a positive pressure in the enclosureto help prevent infectious agents from entering the sterile site 52.

FIGS. 208-209 illustrate the ability of the sterile site apparatus 1 andits housing 41 am to form enclosures where an object (not shown), suchas a chemical or medical device, can be placed or manipulated whileisolating the object from the user and infectious agents contained inthe ambient surroundings. While the sterile site apparatus 1 in FIGS.208-209 shows three connected enclosures, more or fewer enclosures ofvarious designs may be used in place of or in conjunction with thoseshown. Whenever the object needs to be manipulated by the user, such asmoving the object from one enclosure to the other, the user will inserttheir left and right hands through the left and right glove sleeveentrances 649 and 650, respectively, and into the left and right glovesleeves 647 and 648, respectively. The glove sleeves 647 and 648 willallow the user to manipulate an object inside of an enclosure withoutcoming into direct contact with the object or other contents of theenclosures. It should be noted that before use, the sealing features639, 651, 652, and 653 will be closed and the entrance enclosure 636,primary enclosure 635 and exit enclosure 637 will be sterile to ensurethat the sterile site apparatus 1 does not contain any infectiousagents. The sealing features 639, 651, 652 and 653 can use a variety ofknown technologies to create a seal including but not limited togaskets, zippers, adhesives, and magnetic strips and can used inmultiple locations in conjunction with or in place of those shown inFIGS. 208-209. The sealing feature 639 will create a seal between theambient surroundings and the entrance enclosure 636. The sealing feature651 will create a seal between the entrance enclosure 636 and theprimary enclosure 635. The sealing feature 652 will create a sealbetween the primary enclosure 635 and the exit enclosure 637. Thesealing feature 653 will create a seal between the exit enclosure 637and the ambient surroundings. The entrance enclosure 636, primaryenclosure 635, and exit enclosure 637 will be supported, have theirshape maintained, and held in position by features including but notlimited to the base supports 646, cross supports 645, and protectivematerial 644. The base supports 646 and cross supports 645 can utilizeknown technologies including but not limited to rigid components,flexible components, inflatable components, and collapsible features tomaintain the integrity of the enclosures. The protective material 644that will form the walls of the enclosures and all other materials usedby the sterile site apparatus 1 will be transparent, translucent, oropaque materials that will serve to protect and isolate the user fromconditions within the enclosures including but not limited to hazardousdrugs, chemicals, fumes, vapors, liquids, solids EMR, sharp edges, andhigh pressures.

It is also conceivable that the enclosures 636, 635, and 637 willmaintain their shape by being inflated with combinations of gas, liquid,Cold Atmospheric Plasma (CAP) and/or solid mixtures. The combinations ofgas, liquid, CAP, and/or solid mixtures will be delivered to theentrance enclosure 636, primary enclosure 635, and exit enclosure 637through the inlet ports 640, 642, and 655, respectively. Thecombinations of gas, liquid, CAP, and/or solid mixtures will be removedfrom the entrance enclosure 636, primary enclosure 635, and exitenclosure 637 through the outlet ports 641, 643, and 656, respectively.The inlets ports 640, 642, and 655 and the outlet ports 641, 643, and656 will transfer combinations of gas, liquid, CAP and/or solid mixturesvia the supply cord 40 (FIG. 3). The gas, liquid, CAP and/or solidmixtures can serve a variety of other functions besides inflation whichinclude but are not limited to disinfection, infectious agentdisplacement, and neutralizing hazardous materials. The sterile siteapparatus 1 can also implement EMR emitters 160 ac and 160 ad of theentrance enclosure 636 and the exit enclosure 654, respectively. The EMRemitters 160 ac and 160 ad will create an EMR barrier 161 (FIG. 73),which will serve a variety of functions including but not limited todisinfection, illumination, and ozone gas generation.

FIG. 210 illustrates the ability of the sterile site apparatus 1 to beused for post-operative monitoring of the sterile site 52. For thisconfiguration, the housing 41 aa and possibly the sterile site equipment27 a, which can be connected to each other via the supply cord 40 b,will be attached to the patient 660 during normal day-to-day toactivities. In this instance, the sterile site 52 can represent ahealing wound or a chemotherapy/dialysis access port. The sterile siteapparatus 1 will monitor the conditions of the sterile site 52 to checkfor signs of infection or other complication. Upon recognition of theinfection or other complication, the sterile site apparatus 1 willactivate various features to alert the patient or medical personnel ofthe infection or other complication and/or take measures, such asadministering disinfect fluids, to actively disinfect the sterile site52 to slow the growth of the infection or eliminate it entirely.

FIGS. 211-213 illustrate the ability of the sterile site apparatus 1 tobe attached to an intravenous device 473 to protect the sterile site 52,which is shown as the access location 474 of the intravenous device 473in FIG. 213. For this configuration, the housing 41 bm will at leastpartially surround the sterile site 52 while still allowing access for amedical instrument. The object sensor 3 c would detect an object orinfectious agent as it approaches the sterile site 52. Upon detection ofan object or infectious agent, the object 3 c will send a signal to thecontrol system 20 a, which can be powered by a battery 476, via thetransmission wire 475. The battery 476 and control system 20 a will beconsidered as part of the sterile site equipment 27 b. The configurationin FIG. 213 is unique because the sterile site equipment 27 b iscontained within the housing 41 bm. The control system 20 a will thensend a signal the EMR emitters 160 ae, which will create an EMR barrier161 j to disinfect the incoming object or infectious agent and/or thesterile site 52. This will prevent contamination of an intravenous line,which will reduce the risk of infection by preventing infectious agentsfrom coming into contact with the sterile site 52.

FIGS. 214-221 illustrate the ability of the sterile site apparatus 1 tobe a portable system used to disinfect infectious agents contained inand on an intravenous access device 755. FIGS. 214-217 show the sterilesite apparatus 1 before it has become engaged with the intravenousaccess device 755. FIGS. 218-221 show the sterile site apparatus 1 onceit has become engaged with and is disinfecting the intravenous accessdevice 755 with an EMR barrier 161 k. For the configurations shown inFIGS. 214-221, the infectious agents will be located on the leadinginterior surface 759 and leading exterior surface 760 of the intravenousaccess device 755. The sterile site 52 will be described as the innerportion of the intravenous access device 755 that is distant from theleading interior surface 759 and the leading exterior surface 760. Ifinfectious agents were to come near the sterile site 52, it is possiblethat they would travel through the intravenous access device 755, reachthe patient and cause an infection. The housing 41 ab of the sterilesite apparatus 1 will consist of a rear portion 752 and a front portion753. The front portion 753 will be able to rotate about the housinghinge joint 750. When the sterile site apparatus 1 is not in use, thefront portion 753 can rest in the depressed region 751 to allow for acompact profile. The sterile site apparatus 1 will also have anattachment clip 756 with grip features 758, which will be able to rotateabout the clip hinge joint 757. The attachment clip 756 will allow thesterile site apparatus 1 to be attached to a surface or object and allowfor greater portability. The front portion 753 of the housing 41 ab willcontain a sensor 3 e to detect when the sterile site apparatus 1 andintravenous access device 755 are engaged, an attachment feature 761 toengage the sterile site apparatus 1 with the intravenous access device755, an EMR emitter 160 af to create the EMR barrier 161 k, and an EMRshielding feature 754 to prevent EMR from escaping the enclosure of thefront portion 753, which could cause EMR exposure to the user orpatient. The use of the sensor 3 e is advantageous because the presenceof an intravenous access device 755 will act as a necessary input forthe control system 20 (FIG. 1) to create the EMR barrier 161 k. Toextend the service life of the sterile site apparatus 1 and prevent EMRexposure to the user or patient, the EMR barrier 161 k only needs to beactivated when it is coming into contact with the intravenous accessdevice 755. While the attachment feature 761 is shown as threading, anyknown method(s) for connecting two objects can be used in place of or inconjunction with the threading. While the EMR barrier 161 k is shown asbeing emitted towards the leading interior surface 759 and leadingexterior surface 760 of the intravenous access device 755, the EMRbarrier 161 k may be used on any part of an intravenous access device755. While the EMR shielding feature 754 is shown in FIGS. 214-221 as avalve or membrane that can be crossed by the intravenous access device755, the EMR shielding feature 754 can use any known technologies forsealing around an object.

FIGS. 222-224 illustrate the ability of the sterile site apparatus 1 tocouple two tubular medical devices and disinfect the fluid flowingthrough them. The housing 41 ac of the sterile site apparatus 1 willcontain two couplers 780, which will couple the inlet tubular medicaldevice 782 and outlet tubular medical device 781 to the sterile siteapparatus 1. The couplers 780 will also create seals between the tubularmedical devices and the sterile site apparatus 1 to prevent fluid 785from leaking out into the ambient surroundings. For the configurationshown, fluid 785 will be flowing from the inlet tubular medical device782 to outlet tubular medical device 781. The sterile site 52 will be aportion of the inner region of the outlet tubular medical device 781that is distant from the sterile site apparatus 1. The housing 41 acwill contain features and components including but not limited to a flowsensor 3 h, control system 20 b, battery 476 b, EMR emitters 160 ah,transmission wires 784, EMR emitters 160 ag and fiber optics 320. Theflow sensor 3 h can use any of a number of known technologies to measurethe flow rate of the fluid 785 without contacting the fluid 785. Theflow sensor 3 h, control system 20 b, EMR emitters 160 ah, and EMRemitters 160 ag will be powered by the battery 476 b. Electrical powercan be distributed throughout the sterile site apparatus 1 and itssystems via the transmission wires 784. The control system 20 b willserve to activate, deactivate, and alter the outputs of the sterile siteapparatus 1 based on inputs it receives, such as the flow rate of thefluid 785. Signals for inputs and outputs will also be sent and receivedvia the transmission wires 784. If the flow sensor 3 h detects flowmoving through the sterile site apparatus 1, it will be advantageous todisinfect the fluid 785 to prevent infectious agents from reaching thesterile site 52. Once the flow sensor 3 h detects flow of the fluid 785,a signal will be sent to the control system 20 b. The control system 20b will then send a signal to the EMR emitters 160 ag and the EMRemitters 160 ah. The EMR emitters 160 ag will generate and emit thedesired wavelength(s) of EMR to form an EMR barrier 161 l. The EMRemitters 160 ah will generate the desired wavelength(s) EMR, transmitthe EMR through fiber optics 320, and emit the EMR from the ends of thefiber optics 320 to form an EMR barrier 161 m. By passing the fluid 785through the EMR barriers 1611 and 161 m, infectious agents will nolonger pose any danger to the sterile site 52. It should be noted thatthe EMR emitters 160 ag and fiber optics 320 can be distributedcontinuously throughout the entire inner surface of the sterile siteapparatus 1. It should be noted that it would be advantageous to locatethe EMR barriers 1611 and 161 m downstream of the flow sensor 3 h andupstream of the sterile site 52. Using this configuration is beneficialbecause it will ensure that any infectious agents in the fluid 785between the flow sensor 3 h and EMR barriers 1611 and 161 m aredisinfected. It should also be noted that the sterile site apparatus 1can have other appearances and features than those in FIGS. 222-224.

FIGS. 225-230 illustrate the ability of the sterile site apparatus 1 topartially or fully surround the exterior surface of a length of atubular medical device 800. The functions, systems, features and otherdetails of the sterile site apparatuses 1 in FIGS. 225-230 will be thesame as those described in FIGS. 222-224 with the exception that thesterile site apparatuses 1 in FIGS. 225-230 will not couple two separatetubular medical devices. FIGS. 225-226 show a top housing component 41ad and bottom housing component 41 an that can be attached to each otherafter being assembled over the tubular medical device 800. FIGS. 227-228show a housing that will consist of two housing components 41 ae and 41af that will be connected along a hinge joint 801, which can be openedand/or closed on the tubular medical device 800 by pushing on bothhandles 802 of the housing components 41 ae and 41 af. FIGS. 229-230show a housing 41 ag that can be slid over and onto the tubular medicaldevice 800.

FIGS. 231-234 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 ah to attach to the exterior of a multi-linetubular medical device 810 and surround several tubular medical devicelines 811 and 812 of the multi-line tubular medical device 810. WhileFIGS. 231-234 show the sterile site apparatus 1 attached to multipletubular medical device lines 811 and 812 of the same multi-line tubularmedical device 810, it is conceivable that the sterile site apparatus 1will attach to tubular medical device lines from multiple tubularmedical devices. For the configuration shown in FIG. 234, fluid will beflowing from left to right in the second tubular medical device line 812and fluid will be flowing from right to left in the first tubularmedical device line 811. The sterile site 52 will be a portion of theinner region of a tubular medical device line that is downstream fromand distant to the sterile site apparatus 1. The housing 41 ah willcontain features and components including but not limited to flowsensors 3 i, control systems 20 c, batteries 476 c, EMR emitters 160 ajand 160 a 1, transmission wires 784 a, and fiber optics 320. The flowsensors 3 i can use any of a number of known technologies to measure theflow rate of the fluid contained within the tubular medical device lines811 and 812 without contacting the fluid. The flow sensors 3 i, controlsystems 20 c, and EMR emitters 160 aj and 160 a 1 will be powered by thebatteries 476 c. Electrical power can be distributed throughout thesterile site apparatus 1 and its systems via the transmission wires 784a. The control system 20 c will serve to activate, deactivate, and alterthe outputs of the sterile site apparatus 1 based on inputs it receives,such as the flow rate of the fluid. Signals for inputs and outputs willalso be sent and received via the transmission wires 784 a. If the flowsensors 3 i detect flow moving through the sterile site apparatus 1, itwill be advantageous to disinfect the fluid to prevent infectious agentsfrom reaching the sterile site 52. Once the flow sensors 3 i detect flowof the fluid, a signal will be sent to the control systems 20 c. Thecontrol systems 20 c will then send a signal to the EMR emitters 160 a 1and 160 aj. The EMR emitters 160 a 1 will generate and emit the desiredwavelength(s) of EMR to form the EMR barriers 161 n. The EMR emitter 160aj will generate the desired wavelength(s) EMR, transmit the EMR throughfiber optics 320, and emit the EMR from the ends of the fiber optics 320to form the EMR barriers 161 t. By passing the fluid through the EMRbarriers 161 n and 161 t, infectious agents will no longer pose anydanger to the sterile site 52. It should be noted that the EMR emitters160 a 1 and fiber optics 320 can be distributed continuously throughoutthe entire inner surface of the sterile site apparatus 1. It should benoted that it would be advantageous to locate the EMR barriers 161 n and161 t downstream of the flow sensor 3 i and upstream of the sterile site52. Using this configuration is beneficial because it will ensure thatany infectious agents in the fluid between the flow sensor 3 i and EMRbarriers 161 n and 161 t are disinfected. It should also be noted thatthe sterile site apparatus 1 can have other appearances and featuresthan those in FIGS. 231-234. While a tubular medical device related toblood dialysis treatment is shown in FIGS. 231-234, any of a number oftubular medical devices may be used in its place. FIGS. 235-237illustrate the ability of the sterile site apparatus 1 and itsassociated housing 41 ai to be inserted into and along the inner surfaceof a tubular medical device 821. For this configuration, the tubularmedical device 821 is located within the internal pathway of a patient820. A tubular medical device 821 can include but is not limited tocentral line catheters, urinary catheters, pacemaker leads, andintubation tubes. The internal pathway of a patient 820 can include butis not limited to respiratory passageways, arteries, veins, and theurinary tract. The sterile site 52 is designated as the inner surface ofthe internal pathway of a patient 820. To prevent infectious agents orbiofilm 822 on the exterior surface of a tubular medical device 821 fromcoming into contact with the sterile site 52, it is advantageous todisinfect the infectious agents or biofilm 822. This can be done byfirst inserting the housing 41 ai through the center of the tubularmedical device 821. The sterile site apparatus 1 and its housing 41 aican then be advanced through and along the tubular medical device 821.Once at the desired location, the sterile site apparatus 1 and itshousing 41 ai will emit an EMR barrier 1610 from EMR emitters 160 ak. Toperform properly, the tubular medical device 821 should be made ofmaterials that will allow the desired wavelength(s) of EMR of the EMRbarrier 1610 to pass through the tubular medical device 821 anddisinfect the infectious agents or biofilm 822. It should be noted thatthe EMR needed for the EMR barrier 1610 can be distributed through thehousing 41 ai using a variety of known technologies including but notlimited to fiber optics, EMR generators, and stimulated emission.

FIGS. 238-240 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 aj to be inserted into the internal pathway ofa patient 820 and over the tubular medical device 821. For thisconfiguration, the tubular medical device 821 is located within theinternal pathway of a patient 820. The sterile site 52 is designated asthe inner surface of the internal pathway of a patient 820. To preventinfectious agents or biofilm 822 on the exterior surface of a tubularmedical device 821 from coming into contact with the sterile site 52, itis advantageous to disinfect the infectious agents or biofilm 822. Thiscan be done by first inserting the housing 41 aj through the internalpathway of a patient 820 and over the tubular medical device 821. Thesterile site apparatus 1 and its housing 41 aj can then be advanced overand along the tubular medical device 821. Once at the desired location,the sterile site apparatus 1 and its housing 41 aj will emit an EMRbarrier 161 p, which is created by the EMR emitters 160 a 1. It shouldbe noted that the EMR needed for the EMR barrier 161 p can bedistributed through the housing 41 aj using a variety of knowntechnologies including but not limited to fiber optics, EMR generators,and stimulated emission.

FIGS. 241-243 illustrate the ability of the sterile site apparatus 1 andits associated housing 41 ak to be inserted into the internal pathway ofa patient 820. For this configuration, the sterile site apparatus 1 andits housing 41 ak have functions and features in addition to those of atubular medical device, which the sterile site apparatus 1 and itshousing 41 ak are replacing. In addition to performing the samefunctions as the tubular medical device it is replacing, the sterilesite apparatus 1 also has the ability to disinfect the outer surface ofthe housing 41 ak, which is a common location for the accumulation ofinfectious agents and biofilm 822. The sterile site 52 is designated asthe inner surface of the internal pathway of a patient 820. To preventinfectious agents or biofilm 822 on the exterior surface of housing 41ak from coming into contact with the sterile site 52, it is advantageousto disinfect the infectious agents or biofilm 822. This can be done byhaving the EMR emitters 160 am emit an EMR barrier 161 q while thehousing 41 ak is still within the patient. It should be noted that theEMR needed for the EMR barrier 161 q can be distributed through thehousing 41 ak using a variety of known technologies including but notlimited to fiber optics, EMR generators, and stimulated emission.

FIGS. 244-248 illustrate the ability of the sterile site apparatus 1 andits housing 41 a 1 to attach to the exterior of a tubular medical device821, emit an EMR barrier 161 r into a contaminated region 835, and emitan EMR barrier 161 r into the tubular medical device 821 where the EMRwill be transmitted and contained within tubular medical device 821. Forthis configuration, the housing 41 a 1 would be made of a semi-rigid orflexible material so that it can be wedged apart and have its gap 830enlarged enough so that the housing 41 a 1 can fit over the tubularmedical device 821. EMR will be delivered to the transmission andemission medium 831 at the attachment face 832, where the housing 41 a 1can be connected to a supply cord 40 (FIG. 3) or other EMR source. Oncethe EMR is within the transmission and emission medium 831, the EMR willbe released from the transmission and emission medium 831. The EMR willbe released towards the contaminated region 835 of the patient 834 andtowards the tubular medical device 821. The contaminated region 835 is aregion of the patient 834 that contains an undesirably high level ofinfectious agents. The sterile site 52 will be defined as the part ofthe patient 834 that is on the boundary between the contaminated region835 and the rest of the patient 834, but is not contaminated byinfectious agents. EMR is released towards the contaminated region 835in order to kill the infectious agents in the contaminated region 835and prevent them from spreading to the sterile site 52. EMR is releasedtowards the tubular medical device 821 in order to have the EMR enter,become contained within, and transmit through the tubular medical device821. The EMR contained transmitted within the tubular medical device 821can then be used for a variety of purposes including but not limited todisinfecting infectious agents on the interior and exterior surfaces ofthe portion of the tubular medical device 821 within the patient.

FIGS. 249-251 illustrate the ability of the sterile site apparatus 1 andits housing 41 ao to attach to the exterior of a tubular medical device821 and use a heating element 2 a to generate heat 843, which can aid inpreventing the infectious agents or biofilm 822 a on the outer surfaceof the patient 834 a from coming into contact with the sterile site 52.For this configuration, the sterile site 52 is the region between thepatient 834 a and the exterior of the tubular medical device 821 and isthe inner region of the tubular medical device 821 that is within thepatient 834 a. The heating element 2 a will generate heat 843 using anyof a number of known technologies including but not limited toresistance heaters, radio frequency heating of a material, andexothermic chemical reactions including but not limited to sodiumacetate trihydrate reactions and ferrous materials reactions. If theheating element 2 a requires additional means, including but not limitedto electricity, heat, or chemical energy, for generating heat 843, thesemeans will be delivered to the heating element 2 a via the power wire841, which can be connected to the supply cord 40 (FIG. 3) (not shown).Heat 843 will be transferred to the tubular medical device 821. Theheated tubular medical device 821 will have the ability to heat theinner surface or fluid contained within the tubular medical device 821and also heat portions of the patient 834 a near the tubular medicaldevice 821. This will also heat infectious agents in these areas.Heating infectious agents is advantageous because elevating thetemperature above a threshold, such as 105 degrees Fahrenheit, has beenshown to significantly slow the rate of growth for a wide range ofinfectious agents. With a decreased rate of growth, the heatedinfectious agents will have a lower risk of causing infection. Heatingthe regions of the patient 834 a near infectious agents is additionallyadvantageous because and elevated body temperature has been shown toenhance the ability of the immune system to defend against infectiousagents. Heating at higher heats such as 300 degrees Fahrenheit willserve to disinfect infectious agents on the inner and outer surfaces ofthe tubular medical device 821.

FIGS. 252-254 illustrate the ability of the sterile site apparatus 1 andits housing 41 ap to attach to the exterior of a tubular medical device821 and use an electromagnetic field generator 844 to generate anelectric field 845, which can aid in preventing the infectious agents ofbiofilm 822 a on the outer surface of the patient 834 a from coming intocontact with the sterile site 52. For this configuration, the sterilesite 52 is the region between the patient 834 a and the exterior of thetubular medical device 821 and is the inner region of the tubularmedical device 821 that is within the patient 834 a. The electromagneticfield generator 844 will generate an electric field 845 using any of anumber of known technologies such as pulsed electrical field (PEF),alternating current electric field, direct current electric field, or ahigh frequency electric field. If the electromagnetic field generator844 requires additional means, including but not limited to electricity,for generating the electric field 845, these means will be delivered tothe electromagnetic generator 844 via the power wire 841 a, which can beconnected to the supply cord 40 (FIG. 3) (not shown). The electric field845 will act on the tubular medical device 821, the fluid containedwithin the tubular medical device 821, the region of the patient 834 anear the sterile site apparatus 1, and the infectious agents containedin those areas. Using an electric field 845 on infectious agents isadvantageous because electric fields 845 have been shown to eliminate orreduce the growth rate of infectious agents. With a reduce number ofinfectious agents or a decreased growth rate of infectious agents, therewill be a lower risk of infection.

FIGS. 255-256 show the ability of the sterile site apparatus 1 and itsassociated housing 41 bn to use several features to reduce risk ofinfection and retract body tissue 547 a. It should be noted that housing41 bn can be configured in any geometry and out of any materials toserve the function of retracting body tissue 547 a. The opening/closingfeature 130 a will alter the sterile site apparatus 1 and serve toincrease the size, decrease the size, and maintain the shape of theopening used to access the sterile site 52. The retracting feature 542 awill hold back body tissue 547 a in order to maintain the shape and sizeof the opening leading to the sterile site 52. The retracting feature542 will also prevent infectious agents on the exterior surface of thebody tissue 547 a from touching objects, such as medical instruments orthe user's hand, which will come into contact with the sterile site 52.The sterile site apparatus 1 can also use heating elements 2 b and 2 c,which can be located internally or externally to the sterile siteapparatus 1 as seen in FIG. 256, to heat infectious agents and bodytissue 547 a. Heat will slow the growth rate of the infectious agentsand also boost the immune response of the patient. Both of these effectswill reduce the risk of infection. Conductive materials 846 can be usedto effectively deliver heat from a heating element 2 b to a targetedarea. Highly conductive coatings and filler can enhance the ability ofthe sterile site apparatus 1 to transfer heating or cooling to thesterile site 52 and surrounding body tissue 547 a. Coatings 260 a canalso be used anywhere on the sterile site apparatus 1 to serve a varietyof purposes including but not limited to antimicrobial, antibiotic,antiviral, antifungal, and antiparasitic applications.

FIGS. 257-258 illustrate the ability of the sterile site apparatus 1 touse an object sensor 3 c, which is contained in the housing 41 s, todetect an object 91 passing through the detecting region 471. The object91 can be large objects, such as a hand, or smaller slender objects suchas catheters. Depicted in FIGS. 257-258 is an object 91 with twoseparate projections that join 91 b and step down to a smaller profile91 a. When an object 91 passes near or through this detecting region471, two disrupted regions 472 will result corresponding to the twoprojections on object 91. This disruption can be used as a means tocontrol various features of the sterile site apparatus 1. For example,when an object 91 disrupts the detecting region 471, the control system20 (FIG. 1) could cause a feature to disinfect the object 91 as theobject passes through the opening in the sterile site apparatus 1. Ifthe object 91 is a hand, the object sensor 3 c could detect when thehand enters the detecting region 471 and the control system 20 (FIG. 1)could verify that there are five fingers by the number of disruptedregions 472. The object sensor 3 c could further detect if the fingersare spread apart to ensure that there are no shaded areas that might bemore difficult to disinfect. As the object 91 passes through thedetecting region 471, the disrupted region(s) 472 will change as theprofile of the object 91 moves from the joined portion of 91 b to themore slender profile 91 a. This might be useful when detecting a hand toensure that the entire hand has passed through the detecting region 471up to the wrist and provide a signal to the user that they have insertedtheir hands far enough and that they can now be removed.

FIGS. 259-260 illustrate the ability of the sterile site apparatus 1 touse an object sensor 3 c, which is contained in the housing 41 s, todetect an object 91 passing through the detecting region 471. The object91 can be large objects, such as a hand, or smaller slender objects suchas catheters. Depicted in FIGS. 259-260 is an object 91 with twotouching projections that join 91 b and step down to a smaller profile91 a. When an object 91 passes near or through this detecting region471, a single disrupted region 472 will result corresponding to the twotouching projections on object 91. This disruption can be used as ameans to control various features of the sterile site apparatus 1. Forexample, when an object 91 disrupts the detecting region 471, it couldcause a feature to disinfect the object 91 as the object passes throughthe opening in the sterile site apparatus 1. If the object 91 is a hand,the object sensor 3 c could detect when the hand enters the detectingregion 471 and, it could verify that one or more of the fingers aretouching by the number of disrupted regions 472. The control system 20(FIG. 1) could provide a signal to the user that their fingers aretouching and that the disinfection was unable to be performed.

FIGS. 261-263 illustrate the ability of the sterile site apparatus 1 tobe composed of a multitude of various features and systems fordisinfecting an object 91 (not shown), and be in a different locationfrom the sterile site 52 a. While FIGS. 261, 262, and 263 show thesefeatures and systems collectively, it should be noted that some featurescan be omitted and additional features or systems can be included. Thehousing 41 bo is configured with an unobstructed opening 847 that leadsto a passage and allows an object 91 (not shown), or multiple objects tosimultaneously and freely pass through, The positively charged electrode390 b, which is part of the charged particle displacement mechanism 9(FIG. 1), will act to attract or repel infectious agents in a manner toprevent them from coming into contact with an object 91 (not shown). Itshould be noted that although FIG. 263 shows a positively chargedelectrode 390 b being used, a negatively charged electrode can be usedin its place. The gas release opening 31 f will release sterile gas 32or other gas mixtures to displace infectious agents in a way that willprevent them from coming into contact with the object 91 (not shown).The shield 540 b will protect the user from being exposed to EMRreleased at a potentially harmful trajectory. While the EMR barrier 161u, which is created by the EMR emitters 160 as, will be designed toprevent EMR from being released at a potentially harmful trajectory, thesafety feature of using the shield 540 b will help to guarantee thatoperating the sterile site apparatus 1 poses minimal to no danger to theuser. An ergonomic attachment 550 b can be used to improve the comfortand health of the user operating the sterile site apparatus 1, and alsohelp to mount the sterile site apparatus 1 when it is used in adifferent location than the sterile site 52 a. For example, the sterilesite apparatus 1 might be mounted to a wall, to a stand, to an entrance,a recess, or any structure where it would be useful to mount a sterilesite apparatus 1. A detecting region 471 b, which is created by theobject sensor 3 c, can be used to detect a physician's hand, smallobjects, such as a hemostat, and microscopic objects, such as infectiousagents, traveling into or near the sterile site 52. The object sensor 3b will be used to detect objects in the ambient surroundings near thesterile site apparatus 1. The object sensor 3 d will be used to detectobjects that have passed through the EMR barrier 161 u. The objectsensor 3 k, attached to the housing extension 41 bp will be used todetect objects as they move through the EMR barrier 161 u. The abilityto detect the presence of an object near the sterile site apparatus 1will allow certain features of the sterile site apparatus 1 to becontrolled, such as activating the EMR barrier 161 u only when it isneeded, detecting what the object is and altering the intensity of theEMR barrier 161 u. The ability to detect objects that have passedthrough the EMR barrier 161 u will allow certain features of the sterilesite apparatus 1 to be controlled, such as de-activating the EMR barrier161 u when certain features of the object 91 (not shown) have passedthrough. This will prolong the service life of the sterile siteapparatus 1 and minimize exposure to unnecessary radiation andpotentially harmful chemicals. The ability to detect objects as theymove through the EMR barrier 161 u can be used to ensure that the objectis not passing too quickly or too slowly through the EMR barrier 161 u,or to adjust the intensity of the EMR barrier 161 u based on the speedthat the object is travelling. The EMR barrier 161 u can be used todisinfect objects that pass through the opening 847 in the sterile siteapparatus 1 by using the desired wavelength(s) of EMR. The EMR barrier161 u can have a variety of functions including but not limited todisinfection. A coherent EMR barrier will be able to disinfect theentire exterior surface of an object 91 (not shown) as it passes throughthe opening 847. It will also be able to disinfect the exterior ofobjects traveling through the opening 847 even when multiple objects aresimultaneously passing through the sterile site apparatus 1. Sterilesite EMR 577 a, which is released by separate EMR emitters 160 at, willbe released in the area in or near the housing extension 41 bp, where itcan perform a number of functions including but not limited to ozonegeneration, ozone elimination, and illumination. Fluids 8 b will bereleased in the area in or near the housing extension 41 bp by fluidrelease openings 26 d to perform a variety of functions that include butare not limited to mold spore neutralization and infectious agentdisinfection.

As shown in FIG. 264, which is the same as FIG. 77, the housing 41 bq(corresponding to housing 41 d) defines an unobstructed passage 902configured to receive an object. That passage 902 has a proximal inlet900 (corresponding to the plane extending across the top surface of thehousing 41 d in FIG. 77) and a distal outlet 901 (corresponding to theplane extending across the bottom surface of the housing 41 d in FIG.77). The emitters 160 au (corresponding to emitters 160 d in FIG. 77)are positioned to direct electromagnetic radiation into the passage 902defined by the housing 41 bq and being configured to create asubstantially void free barrier 161 v of electromagnetic radiationextending across the passage 902. The barrier 161 v of electromagneticradiation has a proximal extent 903 (e.g., corresponding to theuppermost limit of the beams 184 in FIG. 77), a distal extent 904 (e.g.,corresponding to the lowermost limit of the beams 184 in FIG. 77), and adepth defined by the distance between the proximal extent 903 and thedistal extent 904. As evident in FIG. 77 and FIG. 264, an outerperimeter of an object would not intersect the barrier 161 v when theentire object is proximal to the proximal inlet 900 of the passage 902(i.e., above the inlet in the embodiment shown in FIG. 77 and FIG. 264)or distal to the distal outlet 901 of the passage 902 (i.e., below theoutlet in the embodiment shown in FIG. 77 and FIG. 264) and intersectsthe barrier 161 v when the object passes through the proximal inlet 900to the distal outlet 901. The barrier 161 v therefore creates asubstantially void free intersection of electromagnetic radiation withthe object perimeter corresponding to the depth of the barrier 161 v asthe object passes between the proximal inlet 900 and distal outlet 901of the passage 902.

The words used in this specification to describe the various embodimentsare to be understood not only in the sense of their commonly definedmeanings, but to include by special definition in this specificationstructure, material or acts beyond the scope of the commonly definedmeanings. Thus if an element can be understood in the context of thisspecification as including more than one meaning, then its use in aclaim must be understood as being generic to all possible meaningssupported by the specification and by the word itself.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to include not only thecombination of elements which are literally set forth, but allequivalent structure, material or acts for performing substantially thesame function in substantially the same way to obtain substantially thesame result. In this sense it is therefore contemplated that anequivalent substitution of two or more elements may be made for any oneof the elements in the claims below or that a single element may besubstituted for two or more elements in a claim. Although elements maybe described above as acting in certain combinations and even initiallyclaimed as such, it is to be expressly understood that one or moreelements from a claimed combination can in some cases be excised fromthe combination and that the claimed combination may be directed to asub combination or variation of a sub combination. Insubstantial changesfrom the claimed subject matter as viewed by a person with ordinaryskill in the art, now known or later devised, are expressly contemplatedas being equivalently within the scope of the claims. Therefore, obvioussubstitutions now or later known to one with ordinary skill in the artare defined to be within the scope of the defined elements.

The appended claims are thus to be understood to include what isspecifically illustrated and described above, what is conceptuallyequivalent, what can be obviously substituted and also what essentiallyincorporates the essential idea of the embodiments.

What is claimed is:
 1. An apparatus for creating an electromagneticradiation barrier for a sterile site to inhibit infectious agents fromentering the sterile site, the apparatus comprising: a housing that ispositionable to partially surround the sterile site, the housing havinga curved wall that is not continuous, fully enclosed, or connected allof the way around, the curved wall defining an unobstructed passage thatis sized to receive an object; and at least one emitter ofelectromagnetic radiation coupled to the housing, the at least oneemitter being positioned to direct a field of electromagnetic radiationinto the passage such that infectious agents in proximity to the passageintersect the field of electromagnetic radiation.
 2. The apparatus ofclaim 1, whereby the unobstructed passage surrounds the sterile site byless than 360 degrees.
 3. The apparatus of claim 1, wherein the at leastone emitter creates a substantially void free barrier of electromagneticradiation extending across the passage.
 4. The apparatus of claim 1, thepassage having a proximal inlet and a distal outlet, the electromagneticradiation having a proximal extent, a distal extent, and a depth definedby a distance between the proximal extent and the distal extent, wherebyan outer perimeter of an object (i) does not intersect theelectromagnetic radiation when the entire object is proximal to theproximal inlet of the passage or distal to the distal outlet of thepassage and (ii) intersects the electromagnetic radiation when theobject passes through the proximal inlet to the distal outlet; whereinthe electromagnetic radiation creates a substantially void freeintersection with the object outer perimeter corresponding to the depthof the electromagnetic radiation as the object passes between theproximal inlet and distal outlet of the passage.
 5. The apparatus ofclaim 1, wherein the electromagnetic radiation comprises a UV spectrum,blue light, microwave, pulsed electrical field (PEF), alternatingcurrent electric field, direct current electric field, high frequencyelectric field, or x-ray.
 6. The apparatus of claim 1, wherein theelectromagnetic radiation is ultra violet light having a wavelengthbetween 100 and 280 nm.
 7. The apparatus of claim 1, wherein theelectromagnetic radiation is blue light.
 8. The apparatus of claim 1,wherein the emitter is configured to simultaneously create bothultraviolet light and blue light.
 9. The apparatus of claim 1, whereinthe emitter comprises either light emitting diodes or lasers.
 10. Theapparatus of claim 1, further comprising a sterile sleeve slidablydisposed onto the housing.
 11. The apparatus of claim 10, wherein thesterile sleeve is substantially transparent to the electromagneticradiation.
 12. The apparatus of claim 1, wherein the housing is coupledto a supply cord for providing either power or the electromagneticradiation.
 13. The apparatus of claim 1, further comprising a surgicalretractor coupled to the housing.
 14. The apparatus of claim 1, furthercomprising a surgical retractor coupled to the housing and a sterilesleeve slidably disposed onto the housing.
 15. The apparatus of claim14, wherein the surgical retractor is coupled to the housing over atleast a portion of the sterile sleeve.
 16. The apparatus of claim 14,wherein the surgical retractor comprises an inner perimeter surface andan outer perimeter surface, the inner perimeter surface defining anopening through which the object can access the sterile site, and theouter perimeter surface being configured for contact with the sterilesite.
 17. The apparatus of claim 16, wherein the surgical retractor isdisposed in optical communication with the housing whereby theelectromagnetic radiation is directed to the inner or the outerperimeter surfaces of the surgical retractor.
 18. The apparatus of claim16, wherein the emitter is positioned to direct energy toward the inneror outer perimeter surface of the surgical retractor and is configuredto create a field of energy around the inner or outer perimeter surfacethat is substantially free of voids, wherein an infectious agent inproximity to the inner or outer perimeter surface can intersect thefield.
 19. The apparatus of claim 16, further comprising a movableportion that is configured to adjust a depth, diameter, or shape of theinner or outer perimeter surfaces of the surgical retractor.
 20. Theapparatus of claim 16, further comprising a removable cover forrestricting access to the sterile site.
 21. The apparatus of claim 20,further comprising a valve that is configured to permit access throughthe removable cover.
 22. An apparatus for creating an electromagneticradiation barrier for a sterile site to inhibit infectious agents fromentering the sterile site, the apparatus comprising: a housingconfigured as a surgical retractor that is positionable to partiallysurround the sterile site, the housing having a curved wall that is notcontinuous, fully enclosed, or connected all of the way around, thecurved wall defining an unobstructed passage that is sized to receive anobject; and at least one emitter of electromagnetic radiation coupled tothe housing, the emitter being positioned to direct electromagneticradiation towards an inner or outer perimeter surface of the surgicalretractor and being configured to create a field of electromagneticradiation around the inner or outer perimeter surface that issubstantially free of voids, such that an infectious agent in proximityto the inner or outer perimeter surface intersects the field.
 23. Theapparatus of claim 22, further comprising a sterile sleeve slidablydisposed onto the housing.
 24. The apparatus of claim 23, wherein thesurgical retractor is coupled to the housing over at least a portion ofthe sterile sleeve.
 25. The apparatus of claim 23, wherein the innerperimeter surface defines an opening through which the object can accessthe sterile site, and the outer perimeter surface is configured forcontact with the sterile site.
 26. The apparatus of claim 25, whereinthe surgical retractor is disposed in optical communication with thehousing whereby the electromagnetic radiation is directed to the inneror the outer perimeter surfaces of the surgical retractor.
 27. Theapparatus of claim 25, wherein the emitter is positioned to directenergy toward the inner or outer perimeter surface of the surgicalretractor and is configured to create a field of energy around the inneror outer perimeter surface that is substantially free of voids such thatan infectious agent in proximity to the inner or outer perimeter surfacecan intersect the field.
 28. The apparatus of claim 25, furthercomprising a movable portion that is configured to adjust a depth,diameter, or shape of the inner or outer perimeter surfaces of thesurgical retractor.
 29. The apparatus of claim 25, further comprising aremovable cover for restricting access to the sterile site.
 30. Theapparatus of claim 29, further comprising a valve that is configured topermit access through the removable cover.
 31. The apparatus of claim22, wherein the at least one emitter is positioned to direct a field ofelectromagnetic radiation into the passage.
 32. The apparatus of claim22, wherein the electromagnetic radiation comprises a UV spectrum, bluelight, microwave, pulsed electrical field (PEF), alternating currentelectric field, direct current electric field, high frequency electricfield, or x-ray.
 33. The apparatus of claim 22, wherein theelectromagnetic radiation is ultra violet light having a wavelengthbetween 100 and 280 nm.
 34. The apparatus of claim 22, wherein theelectromagnetic radiation is blue light.